GiViTI - CORDIS · Step-up care 27 29.3 Logistical/organizational reasons 21 22.8 Step-down care 1...

GiViTIGruppo Italiano per la Valutazione degli Interventi In Terapia Intensiva

ReportCREACTIVE project

Year 2016

Overall population (56 ICUs)

CREACTIVE project

2

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3 Project participation

CREACTIVE project

4

Overall population with valid data (56 ICUs) - Year 2016Study flow-chart

(1) Patients with traumatic brain injury are eligible to participate in CREACTIVE (the petal is not activated for patients with maxillofacial fracturesonly).(2) Periods are considered VALID when the % of complete data for core and petal are over the thresholds.(3) Patients older than 17 years are considered ADULT patients.(4) Patients under 17 years of age are considered PEDIATRIC patients.(5) Statistics are only provided for categories of patients composed of at least 5 subjects.

CREACTIVE project

TOTAL RECRUITED PATIENTSN = 21727

PATIENTS ELIGIBLEFOR CREACTIVE(1)

N = 2132

PATIENTS ELIGIBLEFOR CREACTIVE

admitted in VALID periods(2)

N = 1754

ADULT(3)



N = 1635

REPORT(5)

1. All patients

PEDIATRIC(4)



N = 119

REPORT(5)

1. All patients

5 Flow-chart

CREACTIVE project

Flow-chart 6

General report - Year 2016Characteristics on admission - Adult patients

Patients (N): 1635

Sex N %

Male 1207 73.8Female 428 26.2Missing 0

Age (years) N %

17-45 569 34.846-65 463 28.366-75 240 14.7>75 363 22.2

Missing 0Mean 55.1

SD 21.0Median 57Q1−Q3 38−73

Min−Max 17−97

Race N %

White European 1544 95.4White African 15 0.9

Black Afro-american 6 0.4Asian 24 1.5Arab 9 0.6

Nomad 0 0.0Unknown 21 1.3

Missing 16

Marital status: N %

Married 584 36.1Unmarried / Single 336 20.8

Separated / Divorced 46 2.8Cohabiting 60 3.7

Widowed 125 7.7Unknown 467 28.9

Missing 17

Education level N %

No schooling 36 2.2Primary school/ Elementary school 359 22.2

High school diploma 318 19.6University degree 73 4.5

Unknown 833 51.5Missing 16

Occupational status: N %

Worker 454 28.1Student 477 29.5Retired 50 3.1

Unemployed / Looking for work 80 5.0Disabled / Not applicable / Sheltered

employment38 2.4


Body mass Index (BMI) N %

Underweight 59 3.6Normal 887 54.7

Overweight 545 33.6Obese 132 8.1

Missing 12Comorbidities N %

No 740 45.3Yes 895 54.7

Missing 0Comorbidities (top 10) N %

Hypertension 506 30.9Arrhythmia 151 9.2

Alcohol addiction 151 9.2Antiplatelet therapy 139 8.5

Diabetes Type II without insulin tr. 124 7.6Cerebrovascular disease 111 6.8

Drug-induced coagulopathy 94 5.7Myocardial infarction 91 5.6

NYHA class II-III 65 4.0Dementia 55 3.4

Missing 0Multiple trauma N %

No 929 56.8Yes 706 43.2

Missing 0Trauma (anatomical districts) N %

Spine 313 19.1Vertebral fracture, without deficit 272 16.6

Tetraplegia 13 0.8Cervical injury, incomplete deficit 11 0.7

Chest 480 29.4Other injuries of the chest 254 15.5

Traum. haemothorax/pneumothorax 209 12.8Severe lung contusion/laceration 142 8.7

Abdomen 142 8.7Minor injuries of the abdomen 44 2.7

Spleen: Moderate-Severe laceration 39 2.4Liver: Moderate-Severe laceration 38 2.3

Pelvis/bone/joint & muscle 320 19.6Long bone fracture 233 14.3

Multiple fracture of the pelvis 129 7.9Very severe or open fracture of the pelvis 17 1.0

Major vessels injury 37 2.3Neck vessels: dissection/transection 13 0.8

Aorta: rupture/dissection 11 0.7Proximal limbs vessels: transection 7 0.4

Miscellaneous 1 0.1Inhalation injury 1 0.1

- 0 0.0Missing 0

CREACTIVE project

7 Adult patients

General report - Year 2016Timing of admission in ICU - Adult patients

Stay before ICU (days)Mean 1.0

SD 5.6Median 0Q1−Q3 0−1Missing 1

Source of admission N %

Same hospital 1297 79.3Other hospital 335 20.5

Long-term chronic care hospital 3 0.2Directly from the community 0 0.0

Missing 0

Ward of admissionSame hospital (N=1297) N %

Medical ward 27 2.1Surgical ward 207 16.0

Emergency room 993 76.6Other ICU 43 3.3

High dependency care unit 27 2.1Missing 0

Ward of admissionOther hospital (N=335) N %




Reason for transfer fromOther ICU (N=92) N %

Specialist expertise 43 46.7Step-up care 27 29.3

Logistical/organizational reasons 21 22.8Step-down care 1 1.1

Missing 0

Access type ° N %

Primary 1300 79.5Secondary 335 20.5

Within 48 hours 272 85.0Over 48 hours 48 15.0

Missing 15Missing 0

Time of trauma available N %

No 400 24.8Yes 1213 75.2

Missing 22

Hours between trauma and admission in ICUTime of trauma available (N=1213)

Mean 13.6SD 24.9

Median 5Q1−Q3 3−10

Min−Max 0−178Missing 0

Hours between trauma and admission in ICUTime of trauma available - Same hospital (N=994)

Mean 12.5SD 23.6



Hours between trauma and admission in ICUTime of trauma available - Other hospital (N=216)

Mean 18.7SD 29.2

Median 7.5Q1−Q3 5−17


Hours between trauma and admission in ICUTime of trauma available - Same hospital - Emergency room (N=800)

Mean 8.1SD 15.3



Hours between trauma and admission in ICUTime of trauma available - Other hospital - Emergency room (N=176)

Mean 12.1SD 15.8



° This information is not requested in the CRF. It is therefore calculated based on the number of hours/days elapsing between the trauma eventand admission to hospital.

CREACTIVE project

Adult patients 8

General report - Year 2016Characteristics of the trauma - Adult patients

Type of traumatic brain injury N %

Penetrating 46 2.9Closed 1557 96.5


Workplace accident N %

No 1441 89.3Yes 116 7.2


Home/domestic accident N %

No 1045 64.8Yes 501 31.1


Road traffic incident N %

No 914 56.7Yes 699 43.3

Missing 22

Means of transportRoad traffic incident (N=699) N %

Truck/bus 11 1.6Car/van 213 30.5

Motorcycle 170 24.3Bicycle 114 16.3

Pedestrian 172 24.6Other 19 2.7

Missing 0

Sport/recreational accident N %

No 1457 90.3Yes 89 5.5


Intention N %

Accidental 1397 86.6Self-inflicted injury 52 3.2

Violence 38 2.4Other 9 0.6


Trauma Dynamics N %

High energy impact with helmet 156 9.7High energy impact without helmet 623 38.6

Low energy impact with helmet 39 2.4Low energy impact without helmet 608 37.7

Blunt object 56 3.5Crush 21 1.3Blast 5 0.3

Gunshot 14 0.9Acceleration/deceleration 132 8.2


CREACTIVE project

9 Adult patients

General report - Year 2016Type of trauma - Adult patients

Type of lesion ° N Alone With G With H With G+HDiffuse Injury * 166 76 45 26 19

Focal Damage ** 1320 530 260 248 282G: Traumatic subarachnoid haemorrhage 721 90 / 25 /

H: Skull fracture 627 27 25 / /

Marshall Classification N %

Diffuse Injury I (no visible pathology) 164 10.2(D-II) Diffuse injury II 555 34.4

Diffuse Injury III (edema) 124 7.7Diffuse Injury IV (shift>5mm) 76 4.7

(5-EML) Evacuated mass lesion 547 33.9Cerebral contusion/laceration 45 8.2

Extradural/epidural haematoma 96 17.6Traumatic Subdural haematoma 349 63.8

Traumatic intraparenchymal bleeding 57 10.4(6-NEML) Not Evacuated mass lesion 149 9.2

Cerebral contusion/laceration 45 30.2Extradural/epidural haematoma 8 5.4Traumatic Subdural haematoma 54 36.2

Traumatic intraparenchymal bleeding 42 28.2Missing 20

Prevalent lesion: DIFFUSE INJURY (N): 166

Diffuse injury N Alone With G With H With G+HA: Traumatic diffuse injury without oedema 94 52 29 9 4

B: Traumatic diffuse injury with oedema 72 24 16 17 15

Petechiae N %

No 60 36.4Yes 105 63.6

Missing 1

Midline shift>5 mm N %

No 141 85.5Yes 24 14.5

Missing 1

Cistern conditions N %

Normal 109 66.1Compressed or distorted 39 23.6

Absent 17 10.3Missing 1

Presence of focal damage N %

No 97 58.8Yes 68 41.2

Missing 1

Focal lesionPresence of focal damage (N=68) N %

Traumatic subdural hematoma 10 14.7Extradural or epidural hematoma 8 11.8

Contusion and/ or brain laceration 40 58.8Traumatic intraparenchymal hemorrhage 10 14.7

Missing 0

Lesion volume > 25ml(N=68) N %

No 57 83.8Yes 11 16.2

Missing 0

Evacuated mass(N=68) N %

No 64 94.1Yes 4 5.9

Missing 0

° Diffuse injury and focal injury are mutually exclusive. Where both are present, the clinician is requested to select and indicate the prevalentinjury.* Traumatic diffuse injury without oedema, Traumatic diffuse injury with oedema.** Cerebral contusion/laceration, Extradural/epidural haematoma, Traumatic Subdural haematoma, Traumatic intraparenchymal bleeding.

CREACTIVE project

Adult patients 10

General report - Year 2016Type of trauma - Adult patients

Prevalent lesion: FOCAL DAMAGE (N): 1320

Focal damage N Alone With G With H With G+HC: Cerebral contusion/laceration 409 124 86 88 111

D: Extradural/epidural haematoma 151 71 11 45 24E: Traumatic Subdural haematoma 589 274 119 94 102

F: Traumatic intraparenchymal bleeding 171 61 44 21 45

Lesion volume > 25ml N %

No 740 56.6Yes 568 43.4

Missing 12

Evacuated mass N %

No 765 58.5Yes 543 41.5

Missing 12

Petechiae N %

No 855 65.4Yes 453 34.6

Missing 12


No 738 56.4Yes 570 43.6

Missing 12




FOCAL DAMAGE (prevalent or compresent) (N): 1388


No 797 57.9Yes 579 42.1

Missing 12


No 787 57.2Yes 589 42.8

Missing 12

Evacuated mass N %

No 829 60.2Yes 547 39.8

Missing 12




FOCAL DAMAGE (prevalent or compresent) withevacuated mass (N): 547

FOCAL DAMAGE (prevalent or compresent) withoutevacuated mass (N): 829


No 117 21.4Yes 430 78.6

Missing 0


No 127 23.2Yes 420 76.8

Missing 0





No 680 82.0Yes 149 18.0

Missing 0


No 660 79.6Yes 169 20.4

Missing 0




CREACTIVE project

11 Adult patients

General report - Year 2016Glasgow Coma Scale - Adult patients

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Glasgow Coma Scale (%)

0

5

10

15

20

25

30GCS pre−treatmentOn admissionWorst value in the first 24 hours

GCS GCSPre(N) GCSPre(%) GCSAdm(N) GCSAdm(%) GCSWorst24(N) GCSWorst24(%)3 275 17 236 20.2 258 244 83 5.1 74 6.3 67 6.25 79 4.9 65 5.6 50 4.76 98 6.1 99 8.5 84 7.87 124 7.7 130 11.1 121 11.38 109 6.7 73 6.2 57 5.39 81 5 76 6.5 66 6.2

10 74 4.6 52 4.5 51 4.811 52 3.2 36 3.1 29 2.712 84 5.2 52 4.5 42 3.913 135 8.4 89 7.6 81 7.514 124 7.7 76 6.5 74 6.915 297 18.4 110 9.4 93 8.7

Tot 1615 100 1168 100 1073 1003-8 637 59.4

9-13 269 25.114-15 167 15.6

GCS pre-treatmentMedian 9Q1−Q3 5−14Missing 20

GCS (admission)Median 7Q1−Q3 4−12

Not evaluable 462Missing 1

Worst GCS (first 24 hours)Median 7Q1−Q3 4−12


Worst GCS during first 24h: bestmotor response

N %

Obeys commands (6) 299 18.3Localizes pain (5) 289 17.7

Withdraws to pain (4) 171 10.5Flexion (abnormal) to pain (3) 65 4.0

Extension to pain (2) 84 5.1None(1) 316 19.3

Not available 410 25.1Missing 1

GCS trend in 48hAvailable information (N=1119) N %

GCS 3 stable 117 10.5GCS from 3 to 4-8 31 2.8GCS from 3 to > 8 31 2.8GCS from 4-8 to 3 59 5.3

GCS 4-8 stable 155 13.9GCS from 4-8 to > 8 102 9.1

GCS from > 8 to 3 50 4.5GCS from > 8 to 4-8 133 11.9

GCS > 8 stable 441 39.4Missing 0

CREACTIVE project

Adult patients 12

General report - Year 2016Before admission to ICU - Adult patients

Availability of the pre-ICU systolicblood pressure value

N %

No 402 24.9Yes 1211 75.1

Missing 22

Clinically relevant hypotension N %

No 1262 78.2Yes 212 13.1


(Lowest) systolic blood pressure valueMean 120.5

SD 33.5Median 120Q1−Q3 100−140


Availability of pre-ICU hypoxiavalue

N %

No 439 27.2Yes 1174 72.8

Missing 22

Clinically relevant hypoxia N %

No 1050 65.1Yes 391 24.2


(Lowest) peripheral oxygen saturation valueMean 93.4

SD 9.9Median 96Q1−Q3 92−98


Pupils in the emergency roomGCS pre < 15 (N=1318) N %

Bilaterally reactive and/or miotic 858 65.1Unilaterally dilated and non-reactive 231 17.5

Bilaterally dilated and non-reactive 147 11.2Not assessable 21 1.6


Hemoglobin ER (gr/dl)Mean 12.5

SD 2.3Median 12.8Q1−Q3 11.1−14.1

Min−Max 0.4−19.9Not available 191

Missing 22

Blood glucose at ER (mg/dl)Mean 159.1

SD 66.3Median 146Q1−Q3 120−185

Min−Max 4−613Not available 281

Missing 22

CREACTIVE project

13 Adult patients

General report - Year 2016Complications in the ICU - Adult patients

Neurological complications during thestay

N %

No 765 47.4Yes 849 52.6

A: Intracranial hypertension 497 30.8B: Intracranial hypertension refractory or

intractable291 18.1

C: At least one episode of dilated pupilsunreactive to light

332 20.6

D: Reduction of serum sodium 192 11.9E: Post-surgical intracranial bleeding 28 1.7F: Non-surgical intracranial bleeding 17 1.1

G: Seizures 59 3.7H: Drowsiness/agitation/delirium 179 11.1

Missing 21

Neurological complications duringthe stay (top 10)

N %

ABC 148 9.2H 119 7.4A 102 6.3C 76 4.7D 71 4.4

AB 66 4.1AC 34 2.1

G 28 1.7AD 27 1.7

ABD 24 1.5Missing 21

Other complications during the stay N %

Respiratory 246 15.0Atelectasis 131 8.0

Pleural effusion 77 4.7Pneumothorax/Pneumomediastinum 31 1.9

Aspiration pneumonia 21 1.3Moderate ARDS 11 0.7

Cardiovascular 167 10.2Acute severe arrhythmia: tachycardias 57 3.5

Deep venous thrombosis 54 3.3Cardiac arrest 32 2.0

Acute severe arrhythmia: bradycardias 21 1.3Hypertensive crisis 17 1.0

Gastrointestinal and hepatic 65 4.0Paralytic Ileus 25 1.5

Liver Dysfunction Syndrome 9 0.6Gastrointestinal bleeding: lower tract 6 0.4Gastrointestinal bleeding: upper tract 6 0.4

Acute on chronic liver disease 5 0.3Other 74 4.5

Metabolic disorder 34 2.1Nephrourologic disease 15 0.9

Other disease 11 0.7Blunt cerebral vessels trauma 3 0.2

Other skin and/or soft tissue pathology 3 0.2Graft vascular thrombosis 2 0.1

Extremity compartment syndrome (severe) 2 0.1Infections 589 36.0Pneumonia 287 17.6

L.R.T.I. other than pneumonia 143 8.7NON-surgical urinary tract infection 50 3.1

Catheter-related bacteremia (CR-BSI) 44 2.7F.U.O. fever of unknown origin 39 2.4

Primary bacteraemia of unknown origin 36 2.2Clinical sepsis 24 1.5

Upper respiratory tract infection 20 1.2Post-surgical skin/soft tissue infection 11 0.7Ventriculostomy-related CNS infection 11 0.7

Missing 0

CREACTIVE project

Adult patients 14

General report - Year 2016Process indicators - Adult patients

ICP monitoring in Core N %

No 1191 72.8Yes 444 27.2

Missing 0

ICP monitoring in CoreWorst value in the first 24 hours

<= 8 (N=637)N %

No 447 70.2Yes 190 29.8

Missing 0

Neurosurgical operation N %

No 930 57.2Yes 696 42.8

Subdural haematoma evcuation 416 25.6Extradural haematoma evcuation 110 6.8Lobectomy or contusion removal 58 3.6

Primary decompression 147 9.0Secondary decompression 47 2.9

Other neurosurgical procedure 123 7.6Missing 9

Hypothermia N %

No 1618 99.0Yes 17 1.0

Missing 0

External ventricular drainagewithout ICP monitoring

N %

No 1611 98.5Yes 24 1.5

Missing 0

External ventricular drainage withICP monitoring

N %

No 1545 94.5Yes 90 5.5

Missing 0

Barbiturate infusion for refractoryICP

N %

No 1511 93.8Yes 100 6.2

Missing 24

Hyperventilation paCO2<25 mmHg N %

No 1569 97.4Yes 42 2.6

Missing 24

Indomethacin N %

No 1608 99.8Yes 3 0.2

Missing 24

Mannitol (multiple doses) N %

No 1247 77.4Yes 364 22.6

Missing 24

Hypertonic saline N %

No 1419 88.0Yes 193 12.0

Missing 23

Osmotic therapy N %

No 1173 72.8Yes 438 27.2

Missing 24

Sedation/analgesia N %

No 1088 67.5Yes 524 32.5

Missing 23

Propofol infusion for refractory ICP N %

No 1450 90.0Yes 161 10.0

Missing 24

Vasoconstrictor drugsVasoactive drugs in Core (N=891) N %

No 326 37.2Yes 550 62.8

Missing 15

Therapy level N %

None 822 50.3Standard 330 20.2

Intermediate 224 13.7Extreme - medical 212 13.0Extreme - surgical 47 2.9

Missing 0

CREACTIVE project

15 Adult patients

General report - Year 2016Outcome - Adult patients

ICU stay (days)Mean 10.8

SD 11.7Median 7Q1−Q3 2−15


ICU mortality (3) N %

Alive 1255 76.8Dead 379 23.2

Missing 1

Cause of death (4)

Dead (N=370) N %

MOF 43 11.8Comorbidities 25 6.9

Cerebral 275 75.8Hemorrhagic 16 4.4

Not determined 4 1.1Missing 7

Outcome at discharge from ICU (5)

Alive (N=1264) N %

Cannot follow simple commands 381 30.5Can follow simple commands 867 69.5

Missing 16

Hospital stay (days) (1),(2)

Mean 22.1SD 28.8



Hospital mortality (1),(3) N %

Alive 1164 71.5Dead 465 28.5

Missing 2

Last hospital mortality (1) N %

Alive 1131 69.6Dead 493 30.4

Missing 7

Does the patient have language problems?Can follow simple commands

(N=867)N %

No 580 66.9Si 196 22.6

Not assessable 91 10.5Missing 0

Does the patient have motor problems?Alive (N=1264) N %

No 639 51.2Yes 609 48.8

Missing 16

Is the patient oriented in at least one of the following dimensions: space, time, person, context?Can follow simple commands

(N=867)N %

No 284 32.8Yes 524 60.4


(1) Statistics calculated after excluding readmissions (N = 1631).(2) Days between admission to ICU and discharge from hospital.(3) Patients discharged in a preterminal condition (N = 9) were calculated among the deceased.(4) Excluding patients discharged in a preterminal condition.(5) Including patients discharged in a preterminal condition.

CREACTIVE project

Adult patients 16

General report - Year 2016Characteristics on admission - Pediatric patients

Patients (N): 119

Sex N %

Male 87 73.1Female 32 26.9Missing 0

Age N %

Newborn (0-4 weeks) 0 0.01-6 months 2 1.7

6-12 months 5 4.212-24 months 7 5.9

2-4 years 17 14.35-8 years 20 16.8

9-16 years 68 57.1Missing 0

Mean 9.1SD 5.3


Min−Max 0−16

Race N %

White European 52 62.7White African 2 2.4

Black Afro-american 3 3.6Asian 1 1.2Arab 24 28.9

Nomad 0 0.0Unknown 1 1.2

Missing 36

Weight (kg)Newborns (N=0)

MeanSD

MedianQ1−Q3Missing 0

Gestational ageNewborns (N=0) N %

At term 0 0.0Not at term 0 0.0

Missing 0

Comorbidities N %

No 107 89.9Yes 12 10.1

Missing 0Comorbidities (top 10) N %

Asthma 2 1.7Brain and skull malformations 2 1.7

Genetic diseases 2 1.7Autoimmune disease 1 0.8

Cerebrovascular disease 1 0.8Encephalopathy 1 0.8

Gastrointestinal malformations 1 0.8Hemiplegia or paraplegia or quadriplegia 1 0.8

Malignant haematological disease 1 0.8Metastatic cancer 1 0.8

Missing 0Multiple trauma N %

No 73 61.3Yes 46 38.7

Missing 0Trauma (anatomical districts) N %

Spine 8 6.7Vertebral fracture, without deficit 7 5.9Cervical injury, incomplete deficit 1 0.8

- 0 0.0Chest 25 21.0

Severe lung contusion/laceration 13 10.9Other injuries of the chest 13 10.9

Traum. haemothorax/pneumothorax 7 5.9Abdomen 9 7.6

Minor injuries of the abdomen 4 3.4Spleen: Moderate-Severe laceration 2 1.7

Spleen: Massive rupture 2 1.7Pelvis/bone/joint & muscle 22 18.5

Long bone fracture 17 14.3Multiple fracture of the pelvis 5 4.2

- 0 0.0Major vessels injury 3 2.5

Neck vessels: dissection/transection 3 2.5- 0 0.0- 0 0.0

Miscellaneous 0 0.0- 0 0.0- 0 0.0

Missing 0

CREACTIVE project

17 Pediatric patients

General report - Year 2016Timing of admission in ICU - Pediatric patients

Previous ICU admissions N %

None 101 84.9<=2 7 5.9>2 1 0.8


Stay before ICU (days)Mean 0.5

SD 3.1Median 0Q1−Q3 0−0Missing 0

Source of admission N %

Same hospital 87 73.1Other hospital 23 19.3

Long-term chronic care hospital 0 0.0Directly from the community 9 7.6

Missing 0

Ward of admissionSame hospital (N=87) N %




Ward of admissionOther hospital (N=23) N %




Reason for transfer fromOther ICU (N=1) N %

Specialist expertise 0 0.0Step-up care 1 100.0

Logistical/organizational reasons 0 0.0Step-down care 0 0.0

Missing 0

Access type ° N %

Primary 96 80.7Secondary 23 19.3

Within 48 hours 21 95.5Over 48 hours 1 4.5

Missing 1Missing 0

Time of trauma available N %

No 11 9.5Yes 105 90.5

Missing 3

Hours between trauma and admission in ICUTime of trauma available (N=105)

Mean 8.9SD 18.1



Hours between trauma and admission in ICUTime of trauma available - Same hospital (N=78)

Mean 9.5SD 20.5



Hours between trauma and admission in ICUTime of trauma available - Other hospital (N=18)

Mean 9.5SD 9.0

Median 6Q1−Q3 3.2−13.2


Hours between trauma and admission in ICUTime of trauma available - Same hospital - Emergency room (N=69)

Mean 5.9SD 7.6



Hours between trauma and admission in ICUTime of trauma available - Other hospital - Emergency room (N=16)

Mean 8.6SD 8.9

Median 6Q1−Q3 3−8.8


° This information is not requested in the CRF. It is therefore calculated based on the number of hours/days elapsing between the trauma eventand admission to hospital.

CREACTIVE project

Pediatric patients 18

General report - Year 2016Characteristics of the trauma - Pediatric patients

Type of traumatic brain injury N %

Penetrating 9 7.8Closed 107 92.2


Workplace accident N %

No 114 98.3Yes 2 1.7


Home/domestic accident N %

No 80 69.0Yes 35 30.2


Road traffic incident N %

No 61 52.6Yes 55 47.4

Missing 3

Means of transportRoad traffic incident (N=55) N %

Truck/bus 1 1.8Car/van 8 14.5

Motorcycle 10 18.2Bicycle 8 14.5

Pedestrian 28 50.9Other 0 0.0

Missing 0

Sport/recreational accident N %

No 101 87.1Yes 15 12.9


Intention N %

Accidental 108 93.1Self-inflicted injury 4 3.4

Violence 2 1.7Other 0 0.0


Trauma Dynamics N %

High energy impact with helmet 21 18.1High energy impact without helmet 45 38.8

Low energy impact with helmet 2 1.7Low energy impact without helmet 35 30.2

Blunt object 10 8.6Crush 3 2.6Blast 0 0.0

Gunshot 0 0.0Acceleration/deceleration 12 10.3


CREACTIVE project


General report - Year 2016Type of trauma - Pediatric patients

Type of lesion ° N Alone With G With H With G+HDiffuse Injury * 18 11 1 5 1

Focal Damage ** 81 29 3 35 14G: Traumatic subarachnoid haemorrhage 23 4 / 0 /

H: Skull fracture 70 15 0 / /

Marshall Classification N %

Diffuse Injury I (no visible pathology) 24 20.5(D-II) Diffuse injury II 47 40.2

Diffuse Injury III (edema) 14 12.0Diffuse Injury IV (shift>5mm) 4 3.4

(5-EML) Evacuated mass lesion 26 22.2Cerebral contusion/laceration 1 3.8

Extradural/epidural haematoma 20 76.9Traumatic Subdural haematoma 5 19.2

Traumatic intraparenchymal bleeding 0 0.0(6-NEML) Not Evacuated mass lesion 2 1.7

Cerebral contusion/laceration 1 50.0Extradural/epidural haematoma 1 50.0Traumatic Subdural haematoma 0 0.0

Traumatic intraparenchymal bleeding 0 0.0Missing 2

Prevalent lesion: DIFFUSE INJURY (N): 18

Diffuse injury N Alone With G With H With G+HA: Traumatic diffuse injury without oedema 11 8 0 3 0

B: Traumatic diffuse injury with oedema 7 3 1 2 1

Petechiae N %

No 9 50.0Yes 9 50.0

Missing 0


No 17 94.4Yes 1 5.6

Missing 0




Presence of focal damage N %

No 11 61.1Yes 7 38.9

Missing 0

Focal lesionPresence of focal damage (N=7) N %

Traumatic subdural hematoma 2 28.6Extradural or epidural hematoma 1 14.3

Contusion and/ or brain laceration 4 57.1Traumatic intraparenchymal hemorrhage 0 0.0

Missing 0

Lesion volume > 25ml §(N=7) N %

No 5 71.4Yes 2 28.6

Missing 0

Evacuated mass(N=7) N %

No 6 85.7Yes 1 14.3

Missing 0

° Diffuse injury and focal injury are mutually exclusive. Where both are present, the clinician is requested to select and indicate the prevalentinjury.* Traumatic diffuse injury without oedema, Traumatic diffuse injury with oedema.** Cerebral contusion/laceration, Extradural/epidural haematoma, Traumatic Subdural haematoma, Traumatic intraparenchymal bleeding.§ Only for > 10 years old.

CREACTIVE project


General report - Year 2016Type of trauma - Pediatric patients

Prevalent lesion: FOCAL DAMAGE (N): 81

Focal damage N Alone With G With H With G+HC: Cerebral contusion/laceration 35 13 2 14 6

D: Extradural/epidural haematoma 29 12 0 14 3E: Traumatic Subdural haematoma 14 4 1 5 4

F: Traumatic intraparenchymal bleeding 3 0 0 2 1


No 31 81.6Yes 7 18.4

Missing 0

Evacuated mass N %

No 55 68.8Yes 25 31.2

Missing 1

Petechiae N %

No 51 63.7Yes 29 36.2

Missing 1


No 62 77.5Yes 18 22.5

Missing 1




FOCAL DAMAGE (prevalent or compresent) (N): 88


No 33 80.5Yes 8 19.5

Missing 0


No 68 78.2Yes 19 21.8

Missing 1

Evacuated mass N %

No 61 70.1Yes 26 29.9

Missing 1




FOCAL DAMAGE (prevalent or compresent) withevacuated mass (N): 26

FOCAL DAMAGE (prevalent or compresent) withoutevacuated mass (N): 61


No 5 38.5Yes 8 61.5

Missing 0


No 11 42.3Yes 15 57.7

Missing 0





No 28 100.0Yes 0 0.0

Missing 0


No 57 93.4Yes 4 6.6

Missing 0




§ Only for > 10 years old.

CREACTIVE project


General report - Year 2016Glasgow Coma Scale - Pediatric patients

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Glasgow Coma Scale (%)

0

5

10

15

20

25 GCS pre−treatmentOn admissionWorst value in the first 24 hours

GCS GCSPre(N) GCSPre(%) GCSAdm(N) GCSAdm(%) GCSWorst24(N) GCSWorst24(%)3 6 5.2 5 5.8 5 5.44 5 4.3 2 2.3 3 3.25 9 7.8 8 9.3 7 7.56 5 4.3 6 7 6 6.57 9 7.8 8 9.3 11 11.88 9 7.8 5 5.8 5 5.49 7 6 10 11.6 10 10.8

10 10 8.6 3 3.5 2 2.211 5 4.3 3 3.5 3 3.212 12 10.3 7 8.1 10 10.813 15 12.9 12 14 11 11.814 24 20.7 17 19.8 20 21.515 / / / / / /

Tot 116 100 86 100 93 1003-8 37 39.8

9-13 36 38.714 20 21.5

GCS pre-treatmentMedian 10Q1−Q3 7−13Missing 3

GCS (admission)Median 9Q1−Q3 7−13


Worst GCS (first 24 hours)Median 9Q1−Q3 7−13



N %

Obeys commands (5) 49 41.2Localizes pain (4) 22 18.5Flexion to pain (3) 12 10.1

Extension to pain (2) 4 3.4None(1) 6 5.0


GCS trend in 48hAvailable information (N=95) N %

GCS 3 stable 3 3.2GCS from 3 to 4-8 1 1.1GCS from 3 to > 8 1 1.1GCS from 4-8 to 3 1 1.1

GCS 4-8 stable 14 14.7GCS from 4-8 to > 8 10 10.5

GCS from > 8 to 3 0 0.0GCS from > 8 to 4-8 3 3.2

GCS > 8 stable 62 65.3Missing 0

CREACTIVE project


General report - Year 2016Before admission to ICU - Pediatric patients

Availability of the pre-ICU systolicblood pressure value

N %

No 38 32.8Yes 78 67.2

Missing 3

Clinically relevant hypotension N %

No 92 79.3Yes 14 12.1


(Lowest) systolic blood pressure valueMean 104.7

SD 19.8Median 110Q1−Q3 90−116.5


Availability of pre-ICU hypoxiavalue

N %

No 33 28.4Yes 83 71.6

Missing 3

Clinically relevant hypoxia N %

No 80 69.0Yes 28 24.1


(Lowest) peripheral oxygen saturation valueMean 96.0

SD 6.4Median 98Q1−Q3 94.5−99.5


Pupils in the emergency roomGCS pre < 14 (N=92) N %

Bilaterally reactive and/or miotic 72 83.7Unilaterally dilated and non-reactive 11 12.8

Bilaterally dilated and non-reactive 1 1.2Not assessable 1 1.2


Hemoglobin ER (gr/dl)Mean 12.2

SD 1.7Median 12.1Q1−Q3 11.4−13.2

Min−Max 6.3−16.1Not available 17

Missing 3

Blood glucose at ER (mg/dl)Mean 141.0

SD 40.8Median 130Q1−Q3 118.8−153.8

Min−Max 12−279Not available 20

Missing 3

CREACTIVE project


General report - Year 2016Complications in the ICU - Pediatric patients

Neurological complications during thestay

N %

No 73 62.9Yes 43 37.1

A: Intracranial hypertension 31 26.7B: Intracranial hypertension refractory or

intractable10 8.6

C: At least one episode of dilated pupilsunreactive to light

9 7.8

D: Reduction of serum sodium 10 8.6E: Post-surgical intracranial bleeding 0 0.0F: Non-surgical intracranial bleeding 3 2.6

G: Seizures 6 5.2H: Drowsiness/agitation/delirium 9 7.8

Missing 3

Neurological complications duringthe stay (top 10)

N %

A 12 10.3AB 5 4.3

ABC 2 1.7AD 2 1.7AH 2 1.7

D 2 1.7DH 2 1.7

G 2 1.7H 2 1.7

ABCD 1 0.9Missing 3

Other complications during the stay N %

Respiratory 14 11.8Upper resp. tract disease 6 5.0

Atelectasis 4 3.4Mild ARDS 3 2.5

Aspiration pneumonia 1 0.8Haemoptysis 1 0.8

Cardiovascular 1 0.8Pulmonary edema 1 0.8

- 0 0.0- 0 0.0- 0 0.0- 0 0.0

Gastrointestinal and hepatic 3 2.5Gastrointestinal bleeding: upper tract 1 0.8

Gastrointestinal perforation 1 0.8Paralytic Ileus 1 0.8

- 0 0.0- 0 0.0

Other 8 6.7Metabolic disorder 7 5.9

Other disease 1 0.8- 0 0.0- 0 0.0- 0 0.0- 0 0.0- 0 0.0

Infections 15 12.6Pneumonia 6 5.0

L.R.T.I. other than pneumonia 4 3.4Post-surgical CNS infection 2 1.7

Upper respiratory tract infection 2 1.7Ventriculostomy-related CNS infection 2 1.7

Primary bacteraemia of unknown origin 1 0.8Catheter-related bacteremia (CR-BSI) 1 0.8

NON-surgical CNS infection 1 0.8F.U.O. fever of unknown origin 1 0.8

NON-surgical urinary tract infection 1 0.8Missing 0

CREACTIVE project


General report - Year 2016Process indicators - Pediatric patients

ICP monitoring in Core N %

No 83 69.7Yes 36 30.3

Missing 0

ICP monitoring in CoreWorst value in the first 24 hours

<= 8 (N=37)N %

No 21 56.8Yes 16 43.2

Missing 0

Neurosurgical operation N %

No 77 65.3Yes 41 34.7

Subdural haematoma evcuation 4 3.4Extradural haematoma evcuation 22 18.6Lobectomy or contusion removal 1 0.8

Primary decompression 6 5.1Secondary decompression 2 1.7

Other neurosurgical procedure 16 13.6Missing 1

Hypothermia N %

No 117 98.3Yes 2 1.7

Missing 0

External ventricular drainagewithout ICP monitoring

N %

No 116 97.5Yes 3 2.5

Missing 0

External ventricular drainage withICP monitoring

N %

No 112 94.1Yes 7 5.9

Missing 0

Barbiturate infusion for refractoryICP

N %

No 106 91.4Yes 10 8.6

Missing 3

Hyperventilation paCO2<25 mmHg N %

No 111 95.7Yes 5 4.3

Missing 3

Indomethacin N %

No 114 98.3Yes 2 1.7

Missing 3

Mannitol (multiple doses) N %

No 95 81.9Yes 21 18.1

Missing 3

Hypertonic saline N %

No 99 85.3Yes 17 14.7

Missing 3

Osmotic therapy N %

No 89 76.7Yes 27 23.3

Missing 3

Sedation/analgesia N %

No 80 69.0Yes 36 31.0

Missing 3

Propofol infusion for refractory ICP N %

No 102 87.9Yes 14 12.1

Missing 3

Vasoconstrictor drugsVasoactive drugs in Core (N=20) N %

No 0 0.0Yes 20 100.0

Missing 0

Therapy level N %

None 75 63.0Standard 12 10.1

Intermediate 9 7.6Extreme - medical 21 17.6Extreme - surgical 2 1.7

Missing 0

CREACTIVE project


General report - Year 2016Outcome - Pediatric patients

ICU stay (days)Mean 6.1

SD 9.6Median 3Q1−Q3 1−6


ICU mortality (3) N %

Alive 113 95.8Dead 5 4.2

Missing 1

Cause of death (4)

Dead (N=5) N %

MOF 1 20.0Comorbidities 0 0.0

Cerebral 4 80.0Hemorrhagic 0 0.0

Not determined 0 0.0Missing 0

Outcome at discharge from ICU (5)

Alive >=4 years (N=89) N %

Cannot follow simple commands 8 9.2Can follow simple commands 79 90.8

Missing 2

Hospital stay (days) (1),(2)

Mean 13.1SD 11.3



Hospital mortality (1),(3) N %

Alive 111 95.7Dead 5 4.3

Missing 0

Last hospital mortality (1) N %

Alive 111 95.7Dead 5 4.3

Missing 0

Does the patient have language problems?Can follow simple commands

(>=4 years) (N=79)N %

No 67 84.8Si 10 12.7

Not assessable 2 2.5Missing 0

Does the patient have motor problems?Alive (>=4 years) (N=89) N %

No 64 73.6Yes 23 26.4

Missing 2

Is the patient oriented in at least one of the following dimensions: space, time, person, context?Can follow simple commands

(>=4 years) (N=79)N %

No 32 40.5Yes 45 57.0


(1) Statistics calculated after excluding readmissions (N = 116).(2) Days between admission to ICU and discharge from hospital.(3) Patients discharged in a preterminal condition (N = 0) were calculated among the deceased.(4) Excluding patients discharged in a preterminal condition.(5) Including patients discharged in a preterminal condition.

CREACTIVE project


CREACTIVE project

FOLLOW-UP

27 Follow-Up

CREACTIVE project

Follow-Up 28

Overall population with valid data (52 ICUs) - Year 2016Follow-up flow-chart - Adult patients

DISABILITY SECTION

QUALITY OF LIFESECTION

DISABILITYSECTION

MORTALITYSECTION

(1) Patients older than 17 years are considered ADULT patients.(2) Periods are considered VALID when the % of complete data for core and petal are over the thresholds.(3) Patients discharged alive > 6 months from the date of admission.(4) This also includes patients declining to take part in the follow-up study or who are not contactable.(5) Patients deceased in ICU or in hospital.(6) Statistics are presented only for categories of patients represented by at least 5 subjects.

N.B. The % refers to the upper node in the flow chart.

CREACTIVE project

ADULT (1)


admitted in VALID(2) periods

N = 1635

PATIENTSDECEASED(5)

N = 489 (29.9%)

PATIENTS WITHPERFORMABLEFOLLOW-UP(3)

N = 1146 (70.1%)

PATIENTS LOST (4)

TO FOLLOW-UPN = 342 (29.8%)

PATIENTSDECEASED

AT 6 MONTHSN = 54 (4.7%)

PATIENTSALIVE

AT 6 MONTHSN = 750 (65.4%)

PERFORMABLE QOLIBRIN = 275 (36.7%)

PERFORMEDQOLIBRI(6)

N = 273 (99.3%)

PERFORMED GOSe(6)

N = 750 (100%)

29 Follow-up - Flow-chart - Adult patients

CREACTIVE project

Follow-up - Flow-chart - Adult patients 30

General report - Year 2016Follow-Up - ’Mortality’ section: Mortality for main subgroups of patients - Adult patients

Patients (N): 1293

This section presents the mortality-related statistics.Each of the tables provided is divided into two parts:

• the first part of each table (on the left-hand side, printed in black ink) refers to the ICU and the hospital mortality rates foreach patient category.For example, 14.4% of the 569 patients aged between 17 and 45 years died in the ICU, while 15.7% died in hospital; 37.7% ofthe 363 patients aged over 75 years died in the ICU, while 50.4% died in hospital.This part of the table refers to all adult CREACTIVE patients with valid data.

• the second part of each table (on the right-hand side, printed in purple ink) refers instead to adult CREACTIVE patients withvalid data on whom we have 6-month outcome data (alive or dead). The mortality rate at different time points (irrespectiveof the place of death - ICU, hospital, home) is shown for these patients: within 4 days of the trauma event, between 4 and 7days, between 8 and 30 days, and over 30 days.For example, 432 of the valid adult CREACTIVE patients are aged between 17 and 45 years: of these, 10.3% died within 4days of the trauma event, while the remaining 89.7% were still alive at that date. Accordingly, the only patients at risk of dyingbetween 4 and 7 days are the ones still alive at day 4 (432*0.897=388): 6.2% of these 388 died between 4 and 7 days. At thispoint, the only patients at risk of dying between 8 and 30 days are the ones who are still alive at day 8 (i.e., 388*0.938=364);5.3% of these died within 30 days.Hence, the sum of the percentages in each row does not produce 100%, since the denominator on which the rate is calculatedvaries for each column. To be precise, it consists of the number of subjects who are still alive at the start of the observationperiod of each column.

All patients (N=1635) Patients with follow-up (N=1293)

Age N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

17-45 569 14.4 15.7 432 10.3 6.2 5.3 0.946-65 463 21.2 28.8 374 12.4 9.5 13.3 9.166-75 240 25.8 37.9 193 15.5 8.6 22.3 27.8

>75 363 37.7 50.4 294 22.9 17.3 34.9 28.1


Comorbidities N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Yes 895 28.7 39.0 720 16.6 12.2 23.6 19.3No 740 16.5 19.8 573 12.0 7.0 7.1 3.5


Source of admission N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Same hospital 1297 23.1 29.9 1028 14.5 9.5 15.3 10.2Other hospital 335 23.3 31.9 263 14.6 11.3 17.8 14.8

Long-term chronic carehospital

3 33.3 33.3 2 50.0 0.0 0.0 0.0

Directly from the community 0 - - 0 - - - -

? Mortality (%)* from TBI

CREACTIVE project

31 Follow-Up - ’Mortality’ section - Adult patients


All patients (N=1635) Patients with follow-up (N=1293)Type of traumatic braininjury

N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Penetrating 46 28.3 38.6 39 15.4 15.2 25.0 4.8Closed 1557 23.0 30.1 1240 14.3 9.6 15.4 11.3

Unknown 10 30.0 30.0 7 28.6 0.0 20.0 0.0


Worst GCS (first 24 hours) N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

3-8 637 38.8 45.7 557 25.2 12.8 21.5 14.49-13 269 5.9 11.9 194 0.0 4.2 10.4 11.7

14-15 167 3.6 6.0 116 0.9 2.7 4.5 1.9Not evaluable 561 19.6 29.0 425 10.9 11.7 16.3 10.8

All patients (N=1635) Patients with follow-up (N=1293)Worst GCS during first 24h:best motor response


Obeys commands (6) 299 3.0 5.7 215 0.5 1.9 4.8 5.6Localizes pain (5) 289 6.9 11.9 214 0.5 4.3 11.5 7.3

Withdraws to pain (4) 171 21.6 32.9 138 4.3 8.3 22.3 26.6Flexion (abnormal) to pain (3) 65 16.9 30.8 52 7.7 6.4 27.3 12.5

Extension to pain (2) 84 44.0 56.0 72 23.6 29.1 28.2 10.7None(1) 316 60.8 66.1 283 47.0 24.7 28.3 14.8

Not available 410 17.8 27.1 318 7.9 9.6 15.6 10.9


GCS trend in 48h N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

GCS 3 stable 117 70.1 76.9 106 61.3 26.8 36.7 15.8GCS from 3 to 4-8 31 22.6 25.8 23 8.7 9.5 21.1 0.0GCS from 3 to > 8 31 3.2 3.2 20 5.0 0.0 0.0 0.0GCS from 4-8 to 3 59 67.8 69.5 54 55.6 29.2 5.9 25.0

GCS 4-8 stable 155 27.7 35.5 139 8.0 10.3 23.0 14.9GCS from 4-8 to > 8 102 2.9 7.8 73 2.8 1.4 5.9 9.4

GCS from > 8 to 3 50 64.0 68.0 48 37.5 16.7 44.0 14.3GCS from > 8 to 4-8 133 27.8 40.8 113 9.7 12.7 23.6 20.6

GCS > 8 stable 441 4.5 9.1 318 0.0 3.5 7.6 7.9


CREACTIVE project

Follow-Up - ’Mortality’ section - Adult patients 32


All patients (N=1635) Patients with follow-up (N=1293)Clinically relevanthypotension


No 1262 19.5 26.8 1004 10.7 8.7 14.7 11.0Yes 212 41.7 47.2 183 33.3 13.1 18.1 9.3

Not available 139 28.8 37.0 99 16.3 15.9 24.6 15.4


Clinically relevant hypoxia N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

No 1050 21.4 28.4 839 12.6 9.5 15.0 11.3Yes 391 25.1 32.1 318 17.7 8.1 14.2 9.3

Not available 172 29.7 38.6 129 18.1 15.4 25.0 15.2


Pupils in the emergency room N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Bilaterally reactive and/or miotic 860 12.1 19.1 668 4.8 6.2 12.1 10.8Unilaterally dilated and

non-reactive231 35.1 43.3 191 21.6 12.8 23.8 12.1

Bilaterally dilated andnon-reactive

147 76.2 81.0 140 60.0 42.9 31.2 4.5

Not assessable 21 33.3 47.6 17 17.6 21.4 18.2 33.3Not available 60 26.7 37.3 45 20.0 16.7 20.0 20.8

All patients (N=1635) Patients with follow-up (N=1293)Anatomical severity (worst CTwithin 48 hours of admission)


Diffuse Injury I (no visiblepathology)

164 11.0 15.3 114 9.8 3.0 8.2 6.7

(D-II) Diffuse injury II 555 7.4 12.3 429 1.9 2.6 9.2 8.2Diffuse Injury III (edema) 124 39.5 44.7 102 32.4 13.0 15.0 11.8

Diffuse Injury IV (shift>5mm) 76 44.7 48.7 62 25.8 19.6 27.0 11.1(5-EML) Evacuated mass lesion 547 24.1 35.2 443 13.6 12.6 20.2 13.6(6-NEML) Not Evacuated mass

lesion149 66.4 73.8 135 41.5 32.9 43.4 36.7


CREACTIVE project

33 Follow-Up - ’Mortality’ section - Adult patients

CREACTIVE project

Follow-Up - ’Mortality’ section - Adult patients 34

General report - Year 2016Follow-Up - ’Disability’ section - Adult patients

Patients (N): 1293

All patients (N=1258) Alive patients (N=715)GOSe result :* N % N %

Deceased 543 43.2 - -Vegetative state 42 3.3 42 5.9

Severe disability LOWER LEVEL 179 14.2 179 25Severe disability UPPER LEVEL 106 8.4 106 14.8

Moderate disability LOWER LEVEL 81 6.4 81 11.3Moderate disability UPPER LEVEL 90 7.2 90 12.6

Good recovery LOWER LEVEL 101 8.0 101 14.1Good recovery UPPER LEVEL 116 9.2 116 16.2

* patients with ’Pre-trauma disability’ are not analyzed. N=1258 patients, instead of 1293 are analyzed.

Disability for main subgroups of patients - N (%)

Age (years) N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

17-45 417 90 (21.6) 10 (2.4) 102 (24.5) 91 (21.8) 124 (29.7)46-65 361 139 (38.5) 14 (3.9) 84 (23.3) 64 (17.7) 60 (16.6)66-75 192 109 (56.8) 8 (4.2) 47 (24.5) 10 (5.2) 18 (9.4)

>75 288 205 (71.2) 10 (3.5) 52 (18.1) 6 (2.1) 15 (5.2)

Comorbidities N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Yes 698 392 (56.2) 25 (3.6) 146 (20.9) 62 (8.9) 73 (10.5)No 560 151 (27.0) 17 (3.0) 139 (24.8) 109 (19.5) 144 (25.7)

Source of admission N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Same hospital 1000 420 (42.0) 34 (3.4) 227 (22.7) 140 (14.0) 179 (17.9)Other hospital 256 122 (47.7) 8 (3.1) 57 (22.3) 31 (12.1) 38 (14.8)


2 1 (50.0) 0 (0.0) 1 (50.0) 0 (0.0) 0 (0.0)

Directly from the community 0 - - - - -

Type of traumatic braininjury

N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Penetrating 39 19 (48.7) 3 (7.7) 3 (7.7) 9 (23.1) 5 (12.8)Closed 1205 515 (42.7) 39 (3.2) 281 (23.3) 160 (13.3) 210 (17.4)

Unknown 7 3 (42.9) 0 (0.0) 1 (14.3) 1 (14.3) 2 (28.6)

Worst GCS (first 24 hours) N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

3-8 548 312 (56.9) 25 (4.6) 100 (18.2) 52 (9.5) 59 (10.8)9-13 186 46 (24.7) 4 (2.2) 55 (29.6) 32 (17.2) 49 (26.3)

14-15 108 11 (10.2) 1 (0.9) 23 (21.3) 23 (21.3) 50 (46.3)Not evaluable 415 174 (41.9) 12 (2.9) 107 (25.8) 63 (15.2) 59 (14.2)

CREACTIVE project

35 Follow-Up - ’Disability’ section - Adult patients

General report - Year 2016Follow-Up - ’Disability’ section - Adult patients



Obeys commands (6) 207 26 (12.6) 2 (1.0) 52 (25.1) 44 (21.3) 83 (40.1)Localizes pain (5) 202 46 (22.8) 5 (2.5) 63 (31.2) 38 (18.8) 50 (24.8)

Withdraws to pain (4) 136 69 (50.7) 4 (2.9) 28 (20.6) 11 (8.1) 24 (17.6)Flexion (abnormal) to pain (3) 52 23 (44.2) 3 (5.8) 11 (21.2) 3 (5.8) 12 (23.1)

Extension to pain (2) 70 47 (67.1) 6 (8.6) 9 (12.9) 7 (10.0) 1 (1.4)None(1) 282 214 (75.9) 11 (3.9) 31 (11.0) 17 (6.0) 9 (3.2)

Not available 308 118 (38.3) 11 (3.6) 91 (29.5) 50 (16.2) 38 (12.3)

GCS trend in 48h N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

GCS 3 stable 105 90 (85.7) 5 (4.8) 8 (7.6) 1 (1.0) 1 (1.0)GCS from 3 to 4-8 22 8 (36.4) 2 (9.1) 5 (22.7) 4 (18.2) 3 (13.6)GCS from 3 to > 8 18 1 (5.6) 0 (0.0) 4 (22.2) 4 (22.2) 9 (50.0)GCS from 4-8 to 3 54 42 (77.8) 2 (3.7) 8 (14.8) 1 (1.9) 1 (1.9)

GCS 4-8 stable 137 63 (46.0) 9 (6.6) 34 (24.8) 16 (11.7) 15 (10.9)GCS from 4-8 to > 8 67 13 (19.4) 0 (0.0) 15 (22.4) 17 (25.4) 22 (32.8)

GCS from > 8 to 3 48 36 (75.0) 3 (6.2) 3 (6.2) 5 (10.4) 1 (2.1)GCS from > 8 to 4-8 111 59 (53.2) 4 (3.6) 28 (25.2) 6 (5.4) 14 (12.6)

GCS > 8 stable 305 56 (18.4) 5 (1.6) 78 (25.6) 55 (18.0) 111 (36.4)

Clinically relevant hypotension N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

No 975 379 (38.9) 31 (3.2) 237 (24.3) 141 (14.5) 187 (19.2)Yes 178 104 (58.4) 6 (3.4) 32 (18.0) 20 (11.2) 16 (9.0)

Not available 98 54 (55.1) 5 (5.1) 16 (16.3) 9 (9.2) 14 (14.3)

Clinically relevant hypoxia N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

No 819 336 (41.0) 23 (2.8) 198 (24.2) 111 (13.6) 151 (18.4)Yes 307 130 (42.3) 12 (3.9) 72 (23.5) 47 (15.3) 46 (15.0)

Not available 125 71 (56.8) 7 (5.6) 15 (12.0) 12 (9.6) 20 (16.0)

Pupils in the emergency room N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Bilaterally reactive and/or miotic 643 198 (30.8) 25 (3.9) 170 (26.4) 116 (18.0) 134 (20.8)Unilaterally dilated and non-reactive 190 103 (54.2) 9 (4.7) 41 (21.6) 17 (8.9) 20 (10.5)

Bilaterally dilated and non-reactive 140 119 (85.0) 2 (1.4) 11 (7.9) 6 (4.3) 2 (1.4)Not assessable 16 11 (68.8) 0 (0.0) 2 (12.5) 1 (6.2) 2 (12.5)

Not available 45 26 (57.8) 0 (0.0) 10 (22.2) 2 (4.4) 7 (15.6)

Anatomical severity (worst CTwithin 48 hours of admission)


Diffuse Injury I (no visible pathology) 110 28 (25.5) 1 (0.9) 26 (23.6) 25 (22.7) 30 (27.3)(D-II) Diffuse injury II 415 86 (20.7) 11 (2.7) 117 (28.2) 86 (20.7) 115 (27.7)

Diffuse Injury III (edema) 100 57 (57.0) 3 (3.0) 21 (21.0) 6 (6.0) 13 (13.0)Diffuse Injury IV (shift>5mm) 60 38 (63.3) 1 (1.7) 10 (16.7) 7 (11.7) 4 (6.7)

(5-EML) Evacuated mass lesion 430 211 (49.1) 25 (5.8) 101 (23.5) 42 (9.8) 51 (11.9)(6-NEML) Not Evacuated mass

lesion135 116 (85.9) 1 (0.7) 10 (7.4) 4 (3.0) 4 (3.0)

CREACTIVE project

Follow-Up - ’Disability’ section - Adult patients 36

General report - Year 2016Follow-Up - ’Quality of Life’ section - Adult patients

Patients (N): 273

QOLIBRI-OS score:Mean 76.1

SD 21.0Median 79.2Q1−Q3 66.7−91.7

Min−Max 0−100

QOLIBRI-OS score:Anatomical severity (worst CT within 48hours of admission) (N=273)

N % Mean SD Median Q1-Q3

Diffuse Injury I (no visible pathology) 39 14.3 70.4 22.1 75.0 60.4−87.5(D-II) Diffuse injury II 138 50.5 78.1 19.7 83.3 67.7−91.7

Diffuse Injury III (edema) 17 6.2 78.4 16.9 83.3 66.7−91.7Diffuse Injury IV (shift>5mm) 5 1.8 85.0 9.6 83.3 79.2−87.5

(5-EML) Evacuated mass lesion 69 25.3 73.5 23.8 79.2 58.3−91.7(6-NEML) Not Evacuated mass lesion 5 1.8 87.5 8.8 87.5 83.3−95.8

QOLIBRI-OS score:GOSe result (N=264) N % Mean SD Median Q1-Q3

Deceased 0 0.0 - - - -Vegetative state 0 0.0 - - - -Severe disability 63 23.9 60.5 24.1 66.7 41.7−79.2

Moderate disability 77 29.2 72.2 19.3 75.0 62.5−83.3Good recovery 124 47.0 86.6 13.8 91.7 79.2−100

CREACTIVE project

37 Follow-Up - ’Quality of Life’ section - Adult patients

CREACTIVE project

Follow-Up - ’Quality of Life’ section - Adult patients 38

Overall population with valid data (30 ICUs) - Year 2016Follow-up flow-chart - Pediatric patients

DISABILITY SECTION

QUALITY OF LIFESECTION

DISABILITYSECTION

MORTALITYSECTION

(1) Patients under 17 years of age are considered PEDIATRIC patients.(2) Periods are considered VALID when the % of complete data for core and petal are over the thresholds.(3) Patients discharged alive > 5 months from the date of admission.(4) This also includes patients declining to take part in the follow-up study or who are not contactable.(5) Patients deceased in ICU or in hospital.(6) Statistics are presented only for categories of patients represented by at least 5 subjects.

N.B. The % refers to the upper node in the flow chart.

CREACTIVE project

PEDIATRIC (1)


admitted in VALID(2) periods

N = 119

PATIENTSDECEASED(5)

N = 5 (4.2%)

PATIENTS WITHPERFORMABLEFOLLOW-UP(3)

N = 114 (95.8%)

PATIENTS LOST (4)

TO FOLLOW-UPN = 21 (18.4%)

PATIENTSDECEASED

AT 5 MONTHSN = 0 (0%)

PATIENTSALIVE

AT 5 MONTHSN = 93 (81.6%)

PERFORMEDPedsQL(6)

N = 92 (98.9%)

PERFORMED GOSe(6)

N = 93 (100%)

39 Follow-up - Flow-chart - Pediatric patients

CREACTIVE project

Follow-up - Flow-chart - Pediatric patients 40

General report - Year 2016Follow-Up - ’Mortality’ section: Mortality for main subgroups of patients - Pediatric patients

Patients (N): 98

This section presents the mortality-related statistics.Each of the tables provided is divided into two parts:

• the first part of each table (on the left-hand side, printed in black ink) refers to the ICU and the hospital mortality rates foreach patient category.For example, 3% of the 68 patients aged between 9 and 16 years died in the ICU, while 2.9% died in hospital; 0% of the 17patients aged between 2 and 4 years died in the ICU, while 0% died in hospital.This part of the table refers to all pediatric CREACTIVE patients with valid data.

• the second part of each table (on the right-hand side, printed in purple ink) refers instead to pediatric CREACTIVE patientswith valid data on whom we have 5-month outcome data (alive or dead). The mortality rate at different time points(irrespective of the place of death - ICU, hospital, home) is shown for these patients: within 4 days of the trauma event,between 4 and 7 days, between 8 and 30 days, and over 30 days.For example, 55 of the valid pediatric CREACTIVE patients are aged between 9 and 16 years: of these, 3.6% died within 4days of the trauma event, while the remaining 96.4% were still alive at that date. Accordingly, the only patients at risk of dyingbetween 4 and 7 days are the ones still alive at day 4 (55*0.964=53): 0% of these 53 died between 4 and 7 days. At this point,the only patients at risk of dying between 8 and 30 days are the ones who are still alive at day 8 (i.e., 53*1=53); 0% of thesedied within 30 days.Hence, the sum of the percentages in each row does not produce 100%, since the denominator on which the rate is calculatedvaries for each column. To be precise, it consists of the number of subjects who are still alive at the start of the observationperiod of each column.


Age N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Newborn (0-4 weeks) 0 - - 0 - - - -1-6 months 2 50.0 50.0 2 50.0 0.0 0.0 0.0

6-12 months 5 0.0 0.0 5 0.0 0.0 0.0 0.012-24 months 7 0.0 0.0 6 0.0 0.0 0.0 0.0

2-4 years 17 0.0 0.0 13 0.0 0.0 0.0 0.05-8 years 20 10.0 10.0 17 0.0 11.8 0.0 0.0

9-16 years 68 3.0 2.9 55 3.6 0.0 0.0 0.0


Comorbidities N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Yes 12 0.0 0.0 11 0.0 0.0 0.0 0.0No 107 4.7 4.7 87 3.5 2.4 0.0 0.0


Source of admission N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Same hospital 87 2.3 2.3 71 1.4 1.4 0.0 0.0Other hospital 23 4.3 4.3 19 0.0 5.3 0.0 0.0


0 - - 0 - - - -

Directly from the community 9 22.2 22.2 8 25.0 0.0 0.0 0.0


CREACTIVE project

41 Follow-Up - ’Mortality’ section - Pediatric patients


All patients (N=119) Patients with follow-up (N=98)Type of traumatic braininjury


Penetrating 9 0.0 0.0 8 0.0 0.0 0.0 0.0Closed 107 4.7 4.7 90 3.4 2.3 0.0 0.0

Unknown 0 - - 0 - - - -


GCS worst (first 24 hours) N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

3-8 37 10.8 10.8 30 10.0 3.7 0.0 0.09-13 36 0.0 0.0 32 0.0 0.0 0.0 0.0

14 20 0.0 0.0 15 0.0 0.0 0.0 0.0Not evaluable 26 4.0 3.8 21 0.0 5.0 0.0 0.0

All patients (N=119) Patients with follow-up (N=98)Worst GCS during first 24h:best motor response


Obeys commands (5) 49 0.0 0.0 39 0.0 0.0 0.0 0.0Localizes pain (4) 22 0.0 0.0 20 0.0 0.0 0.0 0.0Flexion to pain (3) 12 0.0 0.0 10 0.0 0.0 0.0 0.0

Extension to pain (2) 4 25.0 25.0 3 0.0 33.3 0.0 0.0None(1) 6 50.0 50.0 5 60.0 0.0 0.0 0.0

Not available 26 4.0 3.8 21 0.0 5.0 0.0 0.0


GCS trend in 48h N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

GCS 3 stable 3 66.7 66.7 3 66.7 0.0 0.0 0.0GCS from 3 to 4-8 1 0.0 0.0 1 0.0 0.0 0.0 0.0GCS from 3 to > 8 1 0.0 0.0 1 0.0 0.0 0.0 0.0GCS from 4-8 to 3 1 100.0 100.0 1 100.0 - - -

GCS 4-8 stable 14 7.1 7.1 10 0.0 10.0 0.0 0.0GCS from 4-8 to > 8 10 0.0 0.0 8 0.0 0.0 0.0 0.0

GCS from > 8 to 3 0 - - 0 - - - -GCS from > 8 to 4-8 3 0.0 0.0 3 0.0 0.0 0.0 0.0

GCS > 8 stable 62 0.0 0.0 54 0.0 0.0 0.0 0.0


CREACTIVE project

Follow-Up - ’Mortality’ section - Pediatric patients 42


All patients (N=119) Patients with follow-up (N=98)Clinically relevanthypotension


No 92 1.1 1.1 76 1.3 0.0 0.0 0.0Yes 14 21.4 21.4 13 7.7 16.7 0.0 0.0

Not available 10 11.1 10.0 9 12.5 0.0 0.0 0.0


Clinically relevant hypoxia N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

No 80 1.2 1.2 67 0.0 1.5 0.0 0.0Yes 28 10.7 10.7 23 8.7 4.8 0.0 0.0

Not available 8 14.3 12.5 8 14.3 0.0 0.0 0.0


Pupils in the emergency room N ? ? N ? within 4 ? 4-7 ? 8-30 ? over 30in ICU(%) in H(%) days(%)* days(%)* days(%)* days(%)*

Bilaterally reactive and/or miotic 75 4.0 4.0 65 1.5 3.1 0.0 0.0Unilaterally dilated and

non-reactive11 0.0 0.0 7 0.0 0.0 0.0 0.0

Bilaterally dilated andnon-reactive

1 100.0 100.0 1 100.0 - - -

Not assessable 1 0.0 0.0 1 0.0 0.0 0.0 0.0Not available 1 100.0 100.0 1 100.0 - - -

All patients (N=119) Patients with follow-up (N=98)Anatomical severity (worst CTwithin 48 hours of admission)


Diffuse Injury I (no visiblepathology)

24 0.0 0.0 19 0.0 0.0 0.0 0.0

(D-II) Diffuse injury II 47 2.1 2.1 39 0.0 2.6 0.0 0.0Diffuse Injury III (edema) 14 14.3 14.3 11 9.1 10.0 0.0 0.0

Diffuse Injury IV (shift>5mm) 4 25.0 25.0 3 33.3 0.0 0.0 0.0(5-EML) Evacuated mass lesion 26 4.0 3.8 24 4.3 0.0 0.0 0.0(6-NEML) Not Evacuated mass

lesion2 0.0 0.0 2 0.0 0.0 0.0 0.0


CREACTIVE project

43 Follow-Up - ’Mortality’ section - Pediatric patients

CREACTIVE project

Follow-Up - ’Mortality’ section - Pediatric patients 44

General report - Year 2016Follow-Up - ’Disability’ section - Pediatric patients

Patients (N): 98

All patients (N=98) Alive patients (N=93)GOSe result :* N % N %

Deceased 5 5.1 - -VEGETATIVE STATE 1 1.0 1 1.1

Severe disability LOWER LEVEL 8 8.2 8 8.6Severe disability UPPER LEVEL 7 7.1 7 7.5

Moderate disability LOWER LEVEL 4 4.1 4 4.3Moderate disability UPPER LEVEL 10 10.2 10 10.8

Good recovery LOWER LEVEL 21 21.4 21 22.6Good recovery UPPER LEVEL 42 42.9 42 45.2

* patients with ’Pre-trauma disability’ are not analyzed.

Disability for main subgroups of patients - N (%)

Age N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Newborn (0-4 weeks) 0 - - - - -1-6 months 2 1 (50.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (50.0)

6-12 months 5 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 (100.0)12-24 months 6 0 (0.0) 0 (0.0) 2 (33.3) 0 (0.0) 4 (66.7)

2-4 years 13 0 (0.0) 0 (0.0) 1 (7.7) 3 (23.1) 9 (69.2)5-8 years 17 2 (11.8) 0 (0.0) 1 (5.9) 2 (11.8) 12 (70.6)

9-16 years 55 2 (3.6) 1 (1.8) 11 (20.0) 9 (16.4) 32 (58.2)

Comorbidities N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Yes 11 0 (0.0) 0 (0.0) 3 (27.3) 1 (9.1) 7 (63.6)No 87 5 (5.7) 1 (1.1) 12 (13.8) 13 (14.9) 56 (64.4)

Source of admission N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Same hospital 71 2 (2.8) 1 (1.4) 10 (14.1) 11 (15.5) 47 (66.2)Other hospital 19 1 (5.3) 0 (0.0) 2 (10.5) 3 (15.8) 13 (68.4)


0 - - - - -

Directly from the community 8 2 (25.0) 0 (0.0) 3 (37.5) 0 (0.0) 3 (37.5)

Type of traumatic braininjury


Penetrating 8 0 (0.0) 0 (0.0) 2 (25.0) 3 (37.5) 3 (37.5)Closed 90 5 (5.6) 1 (1.1) 13 (14.4) 11 (12.2) 60 (66.7)

Unknown 0 - - - - -

GCS worst (first 24 hours) N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

3-8 30 4 (13.3) 0 (0.0) 9 (30.0) 4 (13.3) 13 (43.3)9-13 32 0 (0.0) 0 (0.0) 3 (9.4) 4 (12.5) 25 (78.1)

14 15 0 (0.0) 0 (0.0) 1 (6.7) 3 (20.0) 11 (73.3)Not evaluable 21 1 (4.8) 1 (4.8) 2 (9.5) 3 (14.3) 14 (66.7)

CREACTIVE project

45 Follow-Up - ’Disability’ section - Pediatric patients

General report - Year 2016Follow-Up - ’Disability’ section - Pediatric patients



Obeys commands (5) 39 0 (0.0) 0 (0.0) 4 (10.3) 6 (15.4) 29 (74.4)Localizes pain (4) 20 0 (0.0) 0 (0.0) 3 (15.0) 3 (15.0) 14 (70.0)Flexion to pain (3) 10 0 (0.0) 0 (0.0) 4 (40.0) 2 (20.0) 4 (40.0)

Extension to pain (2) 3 1 (33.3) 0 (0.0) 1 (33.3) 0 (0.0) 1 (33.3)None(1) 5 3 (60.0) 0 (0.0) 1 (20.0) 0 (0.0) 1 (20.0)

Not available 21 1 (4.8) 1 (4.8) 2 (9.5) 3 (14.3) 14 (66.7)

GCS trend in 48h N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

GCS 3 stable 3 2 (66.7) 0 (0.0) 1 (33.3) 0 (0.0) 0 (0.0)GCS from 3 to 4-8 1 0 (0.0) 0 (0.0) 1 (100.0) 0 (0.0) 0 (0.0)GCS from 3 to > 8 1 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (100.0)GCS from 4-8 to 3 1 1 (100.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

GCS 4-8 stable 10 1 (10.0) 0 (0.0) 4 (40.0) 1 (10.0) 4 (40.0)GCS from 4-8 to > 8 8 0 (0.0) 0 (0.0) 1 (12.5) 1 (12.5) 6 (75.0)

GCS from > 8 to 3 0 - - - - -GCS from > 8 to 4-8 3 0 (0.0) 0 (0.0) 1 (33.3) 0 (0.0) 2 (66.7)

GCS > 8 stable 54 0 (0.0) 0 (0.0) 5 (9.3) 10 (18.5) 39 (72.2)

Clinically relevant hypotension N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

No 76 1 (1.3) 0 (0.0) 12 (15.8) 11 (14.5) 52 (68.4)Yes 13 3 (23.1) 0 (0.0) 3 (23.1) 0 (0.0) 7 (53.8)

Not available 9 1 (11.1) 1 (11.1) 0 (0.0) 3 (33.3) 4 (44.4)

Clinically relevant hypoxia N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

No 67 1 (1.5) 0 (0.0) 11 (16.4) 11 (16.4) 44 (65.7)Yes 23 3 (13.0) 0 (0.0) 4 (17.4) 1 (4.3) 15 (65.2)

Not available 8 1 (12.5) 1 (12.5) 0 (0.0) 2 (25.0) 4 (50.0)

Pupils in the emergency room N Deceased Vegetative Severe Moderate Goodstate(%) disability(%) disability(%) recovery(%)

Bilaterally reactive and/or miotic 65 3 (4.6) 0 (0.0) 9 (13.8) 11 (16.9) 42 (64.6)Unilaterally dilated and non-reactive 7 0 (0.0) 0 (0.0) 3 (42.9) 0 (0.0) 4 (57.1)

Bilaterally dilated and non-reactive 1 1 (100.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)Not assessable 1 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (100.0)

Not available 1 1 (100.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

Anatomical severity (worst CTwithin 48 hours of admission)


Diffuse Injury I (no visible pathology) 19 0 (0.0) 0 (0.0) 2 (10.5) 3 (15.8) 14 (73.7)(D-II) Diffuse injury II 39 1 (2.6) 0 (0.0) 4 (10.3) 4 (10.3) 30 (76.9)

Diffuse Injury III (edema) 11 2 (18.2) 0 (0.0) 4 (36.4) 1 (9.1) 4 (36.4)Diffuse Injury IV (shift>5mm) 3 1 (33.3) 0 (0.0) 1 (33.3) 0 (0.0) 1 (33.3)

(5-EML) Evacuated mass lesion 24 1 (4.2) 1 (4.2) 4 (16.7) 6 (25.0) 12 (50.0)(6-NEML) Not Evacuated mass

lesion2 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (100.0)

CREACTIVE project

Follow-Up - ’Disability’ section - Pediatric patients 46

General report - Year 2016Follow-Up - ’Quality of Life’ section - Pediatric patients

Patients (N): 92

PedsQL - TOTAL SCOREMean 78.6

SD 22.5Median 88Q1−Q3 68.8−96

Min−Max 5−100

PedsQL - TOTAL SCOREAnatomical severity (worst CT within 48hours of admission) (N=92)

N % Mean SD Median Q1-Q3

Diffuse Injury I (no visible pathology) 19 20.7 91.1 10.3 95.0 85.5−98(D-II) Diffuse injury II 38 41.3 78.8 21.4 88.0 72−94.8

Diffuse Injury III (edema) 8 8.7 69.4 27.1 71.0 45.2−95Diffuse Injury IV (shift>5mm) 2 2.2 53.0 43.8 53.0 37.5−68.5

(5-EML) Evacuated mass lesion 23 25.0 73.0 25.7 76.0 61.5−95(6-NEML) Not Evacuated mass lesion 2 2.2 81.5 9.2 81.5 78.2−84.8

PedsQL - TOTAL SCOREGOSe result (N=92) N % Mean SD Median Q1-Q3

Deceased 0 0.0 - - - -Vegetative state 1 1.1 5.0 - 5.0 5−5Severe disability 14 15.2 49.5 21.5 45.0 35−58.8

Moderate disability 14 15.2 72.7 20.2 77.5 64.2−88.8Good recovery 63 68.5 87.5 14.0 94.0 79.5−97

CREACTIVE project

47 Follow-Up - ’Quality of Life’ section - Pediatric patients

A New Comprehensive Tool-box for Assessment

of Children's Outcome After PICU Admission due

to Traumatic Brain InjuryOn behalf of the CREACTIVE consortium

Presented by Joanne Fleming

Background

CREACTIVE objectives :

To describe the epidemiology of moderate-to-severe TBI in 7 countries

To establish centralized biobank (blood and derived fluids, CSF) and clinical imaging data bank

To build a prognostic model based on clinical and biological data to predict short- and long-term outcomes

To help ICUs in identifying their own specific problems and improving quality of care

To recognize the determinants of optimal vs. suboptimal performance

To identify most effective clinical interventions for optimally treating TBI patients

CREACTIVE structure

The Modular ToolboxModules PICU admission 5-month TC 6-month visit Ages:

Basic +

Emotional

PROSAFE

Discharge rehab

Temperament

SDQ

PTSD

PEDS QL

GOS-e

Rehabilitation

Physical exam

Temperament

SDQ

PTSD

all

3m-7y

4-18

6-18

Sleep Age specific Sleep Q:

BISQ

CHSQ

Carskadon

Age specific Sleep Q:

BISQ

CHSQ

Carskadon

0-3y

3-12y

>12y

Neurocog Temperament Computer:

Attention

Inhibition

Memory

Numerical

Temperament

>4

3mo-7y

Aims of CREACTKids Toolbox

Build a tool for comprehensive assessment of

TBI outcome appropriate to the whole pediatric

spectrum

Develop a tool that is easy to administer and

has good compliance

Web base distribution, data collection &

analysis

CREACTIVE study timeline

WardInjury ICU RehabED

What are we looking for?

Motor Cognitive Behavioral

Impairment

Disability

Participation

Quality of life

Impairment

Any loss or abnormality of

psychological, physiological

or anatomical structure or

function

Sheena L. Carter, Ph.D.

Disability

Any restriction or lack (resulting

from an impairment) of ability to

perform an activity in the manner

or within the range considered

normal for a human being


Participation / Handicap

A disadvantage for a given

individual that limits or prevents

the fulfillment of a role that is

normal


The Toolbox Questionnaires →

Temperament → Three age-specific temperament questionnaires: IBQ, ECBQ and CBQ, used to assess Surgency (positive affect), Negative affect and Effortful control Rothbart, M. K. 1981

SDQ → Strengths and Difficulties Questionnaire Goodman, 1997

Sleep was assessed using → BISQ Sadeh, 2004, CSHQ Owens et al., 2001 & School Sleep Habits Survey Wolfson & Carskadon, 1998

Glasgow Outcome Scale pediatric version extended Beers et al., 2005

PedsQLTM4.0 → measures Physical, emotional, social, and school functioning Varni, J.W., et al. (2003)

University of California Post Traumatic Reaction Index (UCLA-RI) Steinberg et

al., 2004

The Toolbox

Cognitive Tasks → Memory :

N-Back - A working memory task in which the participant is

presented with series of animal pictures. Participant is instructed to touch the screen whenever a targetappears on it

Corsi - A computerized version of the classic Corsi Block taskfor visual (spatial) working memory Corsi, 1972

Inhibition :Go/NoGo - An inhibition assessment task in which participants are required to

touch the screen as quickly as possible when a Go stimulus is presented and inhibit that response when a No-go stimulus is presented Rubia et al., 2000

The Toolbox

Cognitive Tasks → Numerical Cognition :

Dot Comparison - The participant is presented with yellow and blue dots on the screen for a short time. He is then asked to guess which of the two colours has more dots (yellow or blue) Halberda et al. (2008)

Attention :ANT – (Attention network task) - a computerized flanker taskproviding three separate measures for orienting, alerting &

conflict resolution Forns et al., 2014

Practicality & Feasibility

Distribution and synchronization of data:

The CREACTKids ToolBox is based on a central server and is distributed over a secure network

All data are saved on a central server and analyzed centrally

User friendly and easy to use -- including online tutorial and practice lessons

Reasonably short task completion time

Summary

The CREACTKids Toolbox:

Is a novel comprehensive toolbox

Uses state-of-the-art validated tools for assessing sleep, neurocognitive, behavioral, physical and emotional dimensions after TBI

Centrally analyzed and synchronizes with patients clinical information

Web-based distribution

Translated to five languages and can easily be translated into others

Achieves high patient compliance

We will willingly share the CREACTKids toolbox with any research group seeking outcome assessment of post TBI patients

CREACTIVE

Isaac Lazar MDSoroka University Medical Center

and Ben Gurion University of the NegevBeer Sheva, ISRAEL

On Behalf of the CREACTIVE Consortium

Collaborative REsearch on ACute Traumatic brain Injury (TBI) in intensiVe care medicine in Europe

Outcome of Children after Traumatic Brain

Injury

Preliminary results of the CREACTKids study

CREACTIVE

“EU Seventh Framework Program (FP7/2007-13 under Grant Agreement no. 602714 (CREACTIVE)"

CREACTIVE

METHODS

CREACTIVE

Acute Admission Data Collection

CREACTIVECREACTIVE

The CREACTKids Tool Box Injury

PICU Admission 5 month Phone call 6 month “Face to face” meeting

Consent

UCLA –RI PTSD Q

SDQ

Rothbart’s Temperament Q

Age matched Sleep Q

Demographic Q

Peds – QL 4.0 ©

GOS – e Peds

Rehabilitation Q

UCLA –RI PTSD Q

SDQ


Age matched Sleep Q

Neurocognitive tasks

ANT

Corsi

Dot Comparison

Go- No Go

CREACTIVECREACTIVE

RESULTS

CREACTIVECREACTIVE

ICUs Admissions Peds TBI TBI peds %TBI

CY 1 1490 8 112 4 8%

GR 1 476 128 34 7 7%

HU 3 2738 55 484 29 18%

IL 1 58 1661 1 134 8%

IT 33 32612 1760 2848 183 9%

PL 3 152 0 38 0 25%

SI 3 2544 19 416 6 16%

TOT 45 40070 3631 3933 363 10%

CREACTIVE Situation from March 2014 to December 2016

45 ICUs followed 363 pediatric TBI patients

https://www.cia.gov/library/publications/the-world-factbook/flags/pl-flag.html

https://www.cia.gov/library/publications/the-world-factbook/flags/hu-flag.html

https://www.cia.gov/library/publications/the-world-factbook/flags/it-flag.html

https://www.cia.gov/library/publications/the-world-factbook/flags/si-flag.html

CREACTIVECREACTIVE

Study population 2014 – 2016

None 93%

Yes7%

Comorbidity

None Yes

(6.3% Spinal trauma)

CREACTIVECREACTIVE

Patients age distribution

0

11

6

17

33

26

41

0

5

10

15

20

25

30

35

40

45

0-4weeks

1-6months

6-12months

12-24months

2-4 years 5-8 years 9-16years

IL 001 Ages

49% 50%

CREACTIVECREACTIVEInjury type

CREACTIVECREACTIVE

CREACTIVECREACTIVE

52

25

19

5

16

27

20

Intracranialhypertension

Anisocoria Hyponatremia Newintracranial

bleeding

Seizures Cerebraledema

Delirium

Pat

ien

ts

Complications during admission: 94 patients

CREACTIVECREACTIVE

CREACTIVECREACTIVE

Hospital Outcome

• PICU LOS – 5 days (1-161 days)

• Hospital LOS – 11 days (0 – 202)

• On Discharge:

– Can follow simple commands – 92%

• All mortality occurred in the PICU

94%

6%

ICU MORTALITYAlive Dead

CREACTIVECREACTIVE

The CREACTKids Tool Box Injury

PICU Admission 5 month Phone call

Consent

UCLA –RI PTSD Q

SDQ


Age matched Sleep Q

Demographic Q

Peds – QL 4.0 ©

GOS – e Peds

Rehabilitation Q

UCLA –RI PTSD Q

SDQ


Age matched Sleep Q

Neurocognitive tasks

ANT

Corsi

Dot Comparison

Go- No GoFollow UP

6 month “Face to face” meeting

Pre Injury Data

CREACTIVECREACTIVE

Patients - BGU

20 children followed up (17 males/3 females)

Only 5 --> rehab

50% of them, less than 6y.

CREACTIVECREACTIVE

GOSe -Peds Glasgow outcome scale.

1 -> upper good recovery

3 -> Upper moderate Disability

6 -> Lower severe disability

Only two post TBI children

5 months after injury were withsevere disability (upper or lower)

CREACTIVECREACTIVE

CREACTIVECREACTIVE

Strengths & Difficulties Questionnaire (SDQ)

25 questions

Emotional Difficulties

Attention / Hyperactivity

Conduct problems

Peer relations problems

Pro social

Total difficulties

Total Difficulties[F(1,13)=5.5, p<0.05]

CREACTIVECREACTIVE

Emotional difficulties

[F(1,13) = 6.5, p<0.05]

CREACTIVECREACTIVE

Sleep (Duration)

Average night sleep decreased by one hour

CREACTIVECREACTIVE

PTSD

55% of the children had PTSD symptoms:

Intrusive thoughts

Avoidance

Hypervigilance

Enuresis (Bed Wetting)

CREACTIVECREACTIVE

Conclusions

• The CREACTIVE study collects high quality data on TBI patients admitted to ICU in 7 countries

• CREACTKids follows children with TBI from ICU admission to 6 months post injury

• The CREACTKids tool box uses a holistic approach to assess children post TBI outcome and quality of life

• Although most children show overall “good function” or “upper disability”, Difficulties, especially in Emotional, Sleep and PTSD characteristics should be better studied and treated

CREACTIVECREACTIVE We invite any PICU who wishes to join our Pediatric Follow Up study

[email protected]

The role of dedicated neuro-intensive care

units in the treatment of severe TBI

patients: suggestions from

Guido BertoliniGiViTI Coordinating Center

Laboratory of Clinical Epidemiology

IRCCS-Mario Negri Institute for Pharmacological Research – Bergamo. Italy

FP7/2007-13 – under Grant Agreement no. 602714

CREACTIVE

InTBIR consortia

Project Funding agency Target enrolment Study duration Funding

CENTER-TBI5,400

adults and paediatric2013-2020 30,000,000 €

CREACTIVE7,000

adults and paediatric2013-2018 5,400,000 €

TRACK-TBI 2,700 adults 2013-2018 18,800,000 $

ADAPT 1,000 paediatric 2013-2018 16,150,000 $

5P 2,800 paediatric 2013-2018 1,300,000 $

PedCDE 1,000 paediatric 2013-2018 1,400,000 $

Safe to Play 1,000 paediatric 2013-2018 1,500,000 $

PLAYGAME 166 paediatric 2013-2018 850,000 $

NeuroCare 1,700 paediatric 2013-2018 1,000,000 $

TBI-Prognosis 315 adults 2012-2017 1,000,000 $

ITALY

52

CYPRUS

1

SLOVENIA

4

HUNGARY

7

POLAND

4

GREECE

5

ISRAEL

1

CREACTIVE

3.706 patients collected

in 2014-2016

Participating Countries (7) and ICUs (74)

“Do severe TBI patients treated in a

dedicated neuro-intensive care unit

have a more favourable outcome

than those treated in a general

intensive care unit?”

Full ICU (not HDU)

General or neurosurgical unit

Neurosurgery available

Vascular surgery available

Interventional neuroradiology available

Interventional vascular radiology available

CT scan available

MRI available

Structure

at least 40 TBI/year… or …

at least 35 TBI and 100

trauma/year

Case-mix

28 HUBS

(46 SPOKES)

Definition of HUB centres (mixed approach)

Expert review

2.672 patients from 28 HUBS

1.034 patients from 46 SPOKES

Propensity score matched analysis

Matching algorithm: Nearest available matching on

the estimated propensity score





Propensity score matching

Patients characteristicsBefore After Before After

3706 2034 3706 2034

Age – Mean (SD) 55.8 (21.0) 56.3 (20.8) Worst 24 hrs. GCS

Sex – No. (%) Male 2706 (73.0) 1489 (73.2) 3-8 1623 (43,8) 858 (42,2)

Surgical status – No. (%) 9-13 596 (16,1) 371 (18,2)

Non-surgical 1881 (50.8) 1111 (54.6) 14-15 421 (11,4) 310 (15,2)

Elective surgical 25 (0.7) 15 (0.7) NA 1066 (28,8) 495 (24,3)

Emergency surgical 1800 (48.6) 908 (44.6) ICU length of stay – Median (IQR) 7 (2-16) 6 (2-14)

Trauma – No. (%) pure TBI 2009 (54.2) 1153 (56.7) Mean (SD) 10.7 (11.7) 9.9 (11.7)

Multiple trauma 1697 (45.8) 881 (43.3) ICU mortality – No. (%) 849 (22.9) 498 (24.5)

Hours between trauma and ICU adm. Hospital mortality – No. (%) 1119 (30.3) 658 (32.5)

Mean (SD) 12.2 (23.2) 12.1 (24.3) 6-month disability

Median (IQR) 5 (3-9) 4 (2-8) Deceased 1231 (40,8) 721 (43,5)

Marshall Classification Vegetative state 98 (3,2) 53 (3,2)

Diffuse Injury I (no visible pathology) 59 (1.8) 15 (0.8) Severe disability LOWER level 434 (14,4) 198 (11,9)

Diffuse injury II 1335 (40.3) 741 (41.5) Severe disability UPPER LEVEL 252 (8,3) 129 (7,8)

Diffuse Injury III (edema) 303 (9.1) 160 (9.0) Moderate disability LOWER level 135 (4,5) 79 (4,8)

Diffuse Injury IV (shift>5mm) 138 (4.2) 81 (4.5) Moderate disability UPPER LEVEL 259 (8,6) 127 (7,7)

Evacuated mass lesion 1136 (34.3) 564 (31.6) Good recovery LOWER level 272 (9,0) 140 (8,4)

Not Evacuated mass lesion 343 (10.4) 226 (12.6) Good recovery UPPER LEVEL 338 (11,2) 211 (12,7)

NA 392 247 NA 687 376

Axonal injury Intracranial bleeding

Brain contusion/laceration Subdural haematoma

BEFORE AFTER BEFORE AFTER

Basin fracture Maxillofacial fracture

Skull fracture Spinal cord injury


Pre-hospital GCS Hypoxia

Pupils Blood pressure


p-value < 0.001

p-value = 0.009

Overall (N = 2,034)

Propensity < 0.25 (N = 26)

Propensity 0.25 – 0.50 (N = 313)

p-value = 0.01

Propensity 0.50 – 0.75 (N = 845)

p-value = 0.03

Propensity > 0.75 (N = 473)

p-value = 0.47

Including time to centralization

Identify patients who can most benefit from

centralization

Future developments

TBI-dedicated hub centres ensure a higher survival

adjusted rate

The final balance, though, is to produce more disabled

patients

Tentative message

Propensity score distribution

p-value = 0.03

Overall (N = 2,034)

Propensity < 0.25 (N = 26)

Propensity 0.25 – 0.50 (N = 313)

Propensity 0.50 – 0.75 (N = 845)

Propensity > 0.75 (N = 473)

Da : [email protected]

Oggetto : Federal Interagency Conference on TBI 2018 Call for Proposals Submission Confirmation

A : joanne fleming <[email protected]>

Cc : serge masson <[email protected]>, roberto latini <[email protected]>, luca antiga

<[email protected]>, david sharp <[email protected]>

Zimbra [email protected]

Federal Interagency Conference on TBI 2018 Call for Proposals Submission Confirmation

ven, 20 ott 2017, 17:38

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Call for Proposals: 4th Federal Interagency Conference on TBI

Access Key (password): JQVX3994

You can access your abstract any time by clicking here.

Abstract Type: Symposium

Primary Submission Category: Clinical

Abstract Status: Complete

Abstract ID: 357365

Abstract Title: CREACTIVE and BIO-AX-TBI : Integrating Circulating and Neuroimaging Biomarkers to Improve

Phenotyping in TBI

Presenter(s)

Serge Masson, Ph. D. - Senior scientist, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri (Role: Author)

Roberto Latini, M. D. - Head, Department of Cardiovascular Research, Mario Negri Institute for Pharmacological Research (Role:

Presenter)

Luca Antiga, Ph. D. - CEO, Orobix Srl (Role: Presenter)

David J. Sharp, M. D. , PhD - Professor and Consultant Neurologist, Imperial College London (Role: Presenter)

Choose the focus of your abstract

In-depth information communication/knowledge translation (course is intended primarily to impart information)

Did you receive FEDERAL FUNDING for this work?

Yes

If you received FEDERAL FUNDING for this work, please provide the agency or grant number. Type NO, if you did not

receive FEDERAL FUNDING for this work.

EC GA 602714

Learning Objectives

Upon completion, participants will be able to take a more critical approach to interpretation of the role of circulating biomarkers

and brain imaging in the ICU management of moderate-to-severe TBI

1.

Upon completion, participants will be able to describe how circulating biomarkers of inflammatory processes, innate immunity

and brain damage relate to patient characteristics, disease severity and outcomes in TBI

2.

Upon completion, participants will be able to describe how interplay between brain-imaging and circulating biomarkers of

inflammation, innate immunity and brain damage may help clinical assessment /prognosis in moderate-to-severe TBI

3.

Upon completion, participants will be able to describe different methods for investigating axonal injury after traumatic brain4.

Zimbra https://webmail.marionegri.it/zimbra/h/printmessage?id=44435&tz=Euro...

1 di 3 24/05/2018, 14:25

injury and understand approaches to evaluating their utility in a clinical setting

Upon completion, participants will be able to describe methods for quantifying hemorrhagic brain lesions in moderate-to-severe

TBI from CT imaging and assess evolution over time, relating to severity and outcomes.

5.

Presentation Type

Oral Presentation

Body of Abstract

A nested, predefined substudy of the multicenter project, CREACTIVE, aims to enrol 2000 patients in approx. 25 participating centers,

collecting and centrally storing biological samples and clinical imaging data, primarily computed tomography (CT) scans, at ICU

admission and after 4 days and 12 months.

A wide array of circulating biomarkers related to the spheres of brain injury, inflammation and innate immunity were screened in the

preliminary phase in a subgroup of 80 selected patients divided into 3 groups by Glasgow Coma Scale severity. Analysis was based on

multiplex measures of TBI-related biomarkers (12 from Meso Scale Discovery), a panel of 92 inflammation-related protein biomarkers

(Olink Proteomics) and several markers of innate immunity and vascular damage.

The large collection of follow-up scans (2024 scans from 557 patients, as of 20 Oct 2017) has the unique potential to demonstrate how

the characteristics and evolution of hemorrhagic lesions impact on or predict short- and long-term outcomes. In particular, size, shape

and location of hemorrhagic lesions and peri-hemorrhagic edema and their evolution over time are evaluated during the first days of

ICU stay, as are secondary lesions occurring during the stay. Deep learning methods are developed to compute such biomarkers

automatically from CT scans, making quantitative imaging biomarkers available as clinical tools and opening the possibility to extend

their use beyond the CREACTIVE study.

Associations between circulating biomarker and neuroimaging data will be investigated. Updates are regularly shared with InTBIR

Biomarkers Working Group to harmonize the efforts of the European, US and Canadian consortia investigating biomarkers in TBI and to

facilitate the definition of protocols for clinical data and biological sample exchange among partners.

We have just started BIO-AX-TBI, a multicenter study of adult TBI aligned with CREACTIVE. Study will investigate the relationship

between plasma, microdialysis and neuroimaging markers of axonal injury. Advanced magnetic resonance imaging (MRI) methods will

be used to investigate axonal injury after TBI. The relationship between the most promising fluid biomarkers, in particular neurofilament

light (NFL) and tau protein, and MRI will be assessed (N=250). Longitudinal neuroimaging and blood biomarker data will be collected,

allowing assessment of biomarker dynamics and their relation to neurodegeneration measured by brain atrophy. A subgroup of patients

will be assessed using microdialysis (N=40) to investigate local production of NFL and tau. Biomarkers most closely linked to outcome

will be identified from our first cohort (N=250) using logistic regression to model mortality and clinical outcome. These results will be

validated using a larger cohort of patients from CREACTIVE (N=~1000), where we will also investigate the diagnostic utility of CT head

imaging. This will allow us to: (a) cross validate in vivo methods for assessing axonal injury following TBI; (b) test whether combining

measures of axonal injury improves diagnostic and prognostic information; (c) gain insights into underlying mechanisms of axonal

injury.

In conclusion, more precise phenotyping of TBI patients with careful evaluation of circulating and imaging biomarkers in the CREACTIVE

study, in concert with collaborative efforts of the BIO-AX-TBI consortium, is a premise for improving TBI-patient outcomes.

Abbreviated Description

Symposium will share preliminary findings from two aligned European studies. CREACTIVE (N=2000) investigates circulating biomarkers

of TBI-related brain injury, inflammation and innate immunity, and sequential neuroimaging data to explore the characteristics and

evolution of hemorrhagic lesions, and their impact on short/long-term outcomes, developing deep learning methods to compute

biomarkers from scans. BIO-AX-TBI (N=~250) studies the relationship between plasma, microdialysis (N=40) and neuroimaging

markers of axonal injury (AI) following TBI. Aim of BIO-AX-TBI is to cross-validate in vivo methods for assessing AI following TBI; test

whether combining measures of AI improves diagnostic and prognostic information; gain insights into underlying AI mechanisms.

Course Outline

Course Outline

1. Multiplex Assessment of Circulating Markers of Brain Injury, Inflammation and Innate Immunity in the CREACTIVE Study. a.

Serge Masson and Roberto Latini 2. Machine Learning-Based Analysis of Sequential CT Scans on a Large Cohort of Moderate-to-

Severe TBI Patients During ICU Stay and Relation to Outcomes. (25 mins) a. Luca Antiga 3. Moving the Frontiers Forward in the

Development and Validation of Blood and Imaging Biomarkers of Axonal Injury Following Traumatic Brain Injury - the BIO-AX-TBI

Study (25 mins) a. David J Sharp

Content Topics

Life Stages

Young adult - 19 years to 29 years of age, Adult - 30 years to 66 years of age, Older Adult - 67 years and above

Theme 1

Biomarkers


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Theme 2

Neuroimaging

Theme 3

Precision medicine

Key Words

Keyword 1

Biomarkers

Keyword 2

Neuroimaging

Keyword 3

Inflammation

Keyword 4

Phenotyping

Keyword 5

Outcomes

Agreements

I understand that the Federal Interagency Conference may choose to audio or video record my presentation and I

agree to allow distribution of the recording and/or slide presentation as part of the Federal Interagency

Conference web-based programming and other activities. I warrant that the presentation and slides are my own

original work and I have obtained the owner's permission to grant this permission to the Federal Interagency

Conference.

I Agree

Additional Information

Additional Information

Technical Support

Email: [email protected]

Phone: (410) 638-9239


3 di 3 24/05/2018, 14:25

CREACTIVE (Collaborative Research on Acute Traumatic Brain Injury in Intensive Care Medicine in Europe) is a European study participating in the global collaborative International Initiative for Traumatic Brain Research (InTBIR). The study gathers data on moderate-to-severe TBI patients across the age spectrum in seven countries. In the first 4 years, 78 ICUs participated, recruiting a total of 6197 patients (5725 adults; 472 children). Key objectives were to build a prognostic model for short/long-term outcome prediction, improve quality of care through optimization of ICU performance, identify best practices, and develop innovative 6-month and 12-month follow-up packages. The Symposium will present some major preliminary CREACTIVE results, from initial conceptualization to the newly developed study tools and infrastructure, focusing on the following findings: Role of centralization in moderate-to-severe TBI management There is growing global consensus on the benefits of managing moderate-to-severe TBI patients at dedicated, high-volume neurointensive care units, associated with better resource utilization compared to general ICUs and shown to save more lives and improve outcomes. However, analyses of centralization primarily focus on mortality outcomes rather than completing the picture by including residual disability and quality of life measures. Preliminary CREACTIVE findings confirm that TBI-dedicated ICU hubs ensure higher adjusted survival but ultimately produce more severely impaired patients. In determining which patients can most benefit from centralization in terms of long-term outcome, CREACTIVE aims to shift attention towards the long-term implications of severe residual disability on sustainable quality of life. Exploring effect of gender, age and other key demographics on injury type, treatment pathway and outcomes CREACTIVE will exploit its large database to analyse the role of age, gender and other demographics in TBI patient management, addressing their impact on head injury type, treatment and rehabilitation options available across the continuum of care. It will also evaluate rates of change in clinical, functional, behavioral and neurocognitive outcomes as measured at telephone and face-to-face follow-up. Preliminary analyses yielded an adult M/F admissions ratio of 1:2.8, and a lower adult mortality rate in males than in females (29.3% vs 32.4%). CREACTKids toolbox in pediatric follow-up post TBI CREACTKids is the pediatric substudy of CREACTIVE. To assess TBI outcome and quality of life, CREACTKids has its own holistic, age-appropriate, modular toolbox to follow up children for 6 months. Data has currently been analyzed on 472 children from 46 ICUs (of which 5 PICUs). The package is web-based, centrally distributed and saved on the local server. It comes in several languages (and can be translated to others), is easier to administer than most other available tools (each follow-up session lasts less than one hour and can be conducted by a non-specialist), and ensures good compliance, as demonstrated by a preliminary pilot. Test results are analyzed centrally. The toolbox, consisting of structured/semi-structured questionnaires and computer tasks, is designed to evaluate several non-physical effects of TBI, i.e. impact on emotional behaviour, sleep, neurocognitive and motor function. Outcomes have been conceptualized according to the ICIDH classifications of impairment, disability and participation, emphasizing impairment in the various domains.

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