Treatment, outcome and plans for the final phase

Dr Barbara A Gregson

Trial Director

Treatments

Study Flow Chart

• 5 Days GCS Monitoring• Day 5 CT • Discharge / 2 week form

6 month outcome questionnaire

Diagnostic CT

Equipoise

Consent to STICH II

Telephone randomisation service (24 hours) or web service

Initial Conservative Treatment

Early Surgery

STICH II - treatments

• Early surgery– Craniotomy performed as soon as possible

(within 12 hours)– Best medical treatment

• Initial conservative treatment– Best medical treatment– Delayed evacuation if patient deteriorates and

it becomes clinically appropriate

Compliance with treatment allocation: surgery group

• Of those randomised to surgery:

- 43% had surgery in under 3 hours- 27% had surgery between 3-6 hours- 21% had surgery between 6-12 hours- 4% had surgery in over 12 hours- 6% did not have surgery

Compliance with treatment allocation: conservative group

• Of those randomised to initial conservative treatment:– 20% had surgery.

• Of those having surgery:– 32% had surgery in under 12 hours (6% of

total)

Outcomes

Outcome measurement

• Confirm patient’s status (any major adverse events) and address

• Six month structured postal questionnaire sent by STICH Office to patient for completion by patient or carer– Primary

• Extended GOS– Secondary

• Rankin• EuroQol• Residence• Focal deficits• Other problems

• Analysis by intention to treat

Outcome for first 350 patients

• 6 month primary outcome data obtained for 329 (94%) patients (20/04/2011)

• 75 died (23%), • 254 completed postal questionnaires were returned. • 3 patients have withdrawn following randomisation.

• Residence at 6 months – 9% living at home alone 23% with Severe Disability– 78% living with family 51% with SD– 13% in residential/nursing homes 60% with SD in residential

88% with SD in nursing homes.

Modified Rankin Scale at six months

Glasgow Outcome Scale at six months

Outcome and age

Outcome and volume of haematoma

Outcome and GCS

Plans for the final phase

Recruitment rate over time

Six month period patients recruited during period

centre-months of recruitment

patients per centre per month

Dec 06 – May 07 8 20 0.4

June 07 – Nov 07 18 111 0.162

Dec 07 – May 08 32 204 0.157

June 08 – Nov 08 45 314 0.143

Dec 08 – May 09 66 417 0.158

June 09 – Nov 09 71 462 0.154

Dec 09 – May 10 68 515 0.132

June 10 – Nov 10 71 560 0.127

Recruitment pattern by month- up to 31 March 2011

Recruitment pattern by quarter- up to 31 March 2011

Review of progress towards final recruitment target

Target total

Planned recruitment (Extension 29/08/08)

Actual recruitment

Planned recruitment (Dec 2009 to bring on target)

Assuming 15 per month

Assuming 12 per month

Area enlarged in following slide

Review of progress towards final recruitment target

Target total

Planned recruitment (Extension 29/08/08)

Actual recruitment

Planned recruitment (Dec 2009 to bring on target)

Assuming 15 per month

Assuming 12 per month

Publications

Conclusions

• Crossover rates are lower than in STICH but could be lower still.

• Ongoing six month follow up rate is 94%.

• 34% of patients make either a good recovery or have moderate disability according to the Glasgow Outcome Scale.

• To attain our target of 600 patients centres need to continue to develop their patient screening strategies and increase their recruitment rates.

• All sites who recruit patients will be acknowledged in the publication of the final results.

To join the study contact:•

• Website: www.research.ncl.ac.uk/stich

• Email: stich@ncl.ac.uk

• Tel: +44 191 222 5761• Fax: +44 191 222 5762

• Address: Neurosurgical Trials Unit

Newcastle University

3-4 Claremont Terrace

Newcastle upon Tyne

NE2 4AEDepartment of Health Disclaimer: The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Department of Health.