Introduction of « TRIMA » in a Regional Blood Transfusion Organisation Dr Bernard LAMY.
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Transcript of Introduction of « TRIMA » in a Regional Blood Transfusion Organisation Dr Bernard LAMY.
The French National Blood The French National Blood Transfusion EstablishmentTransfusion Establishment
The EFS Auvergne LoireThe EFS Auvergne Loire
2 University Hospitals:
Saint Etienne
Clermont Ferrand
6 Regional Hospitals with Blood Banks
3 Cancerology Units with BMT
The EFS Auvergne LoireThe EFS Auvergne Loire
Among the Blood banks
4 of them are concerned by Platelets Collection
Initial EvaluationInitial Evaluation
Before 2001 Apheresis platelets were prepared in 7 of our blood banks and we used for this:
3 Spectra machines
2 Amicus (Baxter) machines
5 MCS3P (Haemonetics) machines
Initial EvaluationInitial Evaluation
We decided in 2002 to increase our capacity to produce Apheresis platelets and to renew some of our previous Apheresis separators We had the possibility to buy new Amicus systems or to introduce the new system TRIMA
We decided to proceed to the evaluation of this system in the Blood bank of Clermont Ferrand in 2002
Initial EvaluationInitial Evaluation
Our 3 main objectives were to
- Obtain a minimum of 3.5 to 4x1011 platelets per Apheresis Platelet concentrates
- Obtain Apheresis Platelet concentrates in accordance with law requirements
- Limit the time of collection for donor conveniences
Initial EvaluationInitial Evaluation
469 Apheresis were performed and we obtained data suitable for statistics evaluation in 458 procedures
We collected and analysed data from:
- Blood donors, immediately before Apheresis
- Blood donors, immediately after Apheresis
- Apheresis platelets, immediately after collection
- Apheresis platelets, during storage (5 days)
All these data were statistically analysed
Initial EvaluationInitial Evaluation
Mean 1,72Max. 1,96Min. 1,48Mean 75Max. 118Min. 50Mean 4,722Max. 7,04Min. 3,091
Total Blood volume (liter)
Number of donors: 290 Men 168 Women
Size (meter)
Body weight (kg)
Initial EvaluationInitial Evaluation
Mean 3,88
Max. 5,489Min. 3,005Mean 0,93Max. 1,24Min. 0,67Mean 50Max. 66Min. 33
Blood Flow (mL/min)
Blood volume processed (liter)
Equivalent Total Blood Volume
Initial EvaluationInitial Evaluation
Mean 473
Max. 661Min. 334Mean 7/64=0,109Max. 4/23=0,174Min. 3/40=0,075Mean 87Max. 119Min. 61
Collection time (min)
Anticoagulant Volume used (mL)
Anticoagulant Ratio
Mean 15 Mean 14,1Max. 18 Max. 17,2Min. 11,6 Min. 11,2Mean 43 Mean 41,6Max. 52,4 Max. 49,1Min. 33,3 Min. 31Mean 88 Mean 88,3Max. 98,6 Max. 98,3Min. 86,2 Min. 86,9
After
Red Cell Volum
(µ3)
Hemoglobin (g/100mL)
Hematocrit
Before platelets collection
Initial Evaluation: Initial Evaluation: Donors parametersDonors parameters
Initial Evaluation: Initial Evaluation: Donors parametersDonors parameters
Mean 6,64 Mean 6,89Max. 11,4 Max. 11,8Min. 3,37 Min. 3,1Mean 56 Mean 52,8Max. 78,1 Max. 81,3Min. 47,1 Min. 27Mean 32 Mean 35,2Max. 54,4 Max. 58,3Min. 14,2 Min. 10,4
After
Lymphocytes (%)
Leucocytes
(103/mm3)
Polynuclear cells (%)
Before platelets collection
Initial Evaluation: Initial Evaluation: Donors parametersDonors parameters
Mean 260 Mean 176Max. 442 Max. 327Min. 176 Min. 121Mean 7,66 Mean 8,11Max. 11,7 Max. 12,3Min. 5,7 Min. 6,2
Mean 154Max. 455Min. 104
TRIMA Donor's post count
After
Platelets (103/mm3)
Platelets volume
Before platelets collection
Initial Evaluation: Initial Evaluation: Apheresis platelets Apheresis platelets
parametersparameters
The French law requirement is, for the donor,
a minimum of 100.103 Plts after donation
In all the processing, the post donation platelets count was over this value
Initial Evaluation: Initial Evaluation: Apheresis platelets Apheresis platelets
parametersparameters
The amount of platelets collected was:
Mean : 5.31 1011 platelets / unit
+/- 0.85 1011
Initial Evaluation: Initial Evaluation: Apheresis platelets Apheresis platelets
parametersparameters
Mean 7.38Max. 7.59Min. 6.98Mean 7.28Max. 7.37Min. 6.83Mean 7.02Max. 7.11Min. 6.65
pH at J4
pH at J0
pH at J2
Initial Evaluation : Initial Evaluation : Apheresis platelet Apheresis platelet
parametersparameters
Mean 0,065
Max. 0,473Min. 0,002Mean 0,0584Max. 0,731Min. 0,0009
Leucocytes contamination
(WBC106/mm3)Leucocytes
contamination (WBC106/unit)
Law requirements: < 1.106 wbc/unit
All the apheresis platelets were in accordance
Initial Evaluation: Critical data Initial Evaluation: Critical data or processing parametersor processing parameters
* Blood donor initial platelets count:
must be > 200000 / mm3
* Some donors may have some veinous problems (like with other separators). If it is repeated, it is better to propose them plasmapheresis or whole blood donation
* Donors < 50 kg
Initial Evaluation: Critical data Initial Evaluation: Critical data or processing parametersor processing parameters
* Donor parameters must be introduced in the TRIMA Computer before starting the process
Initial Evaluation: Critical data Initial Evaluation: Critical data or processing parametersor processing parameters
Donors were questioned about their feelings of the machine during procedure
No negative comments were collected
They very much appreciated the one arm collection and the reduced time of donation compared to those previously needed with the other machines
Nurses were also questioned about their feelings of the machine
All of them said that it was very easy to use machines
Initial Evaluation: Critical data Initial Evaluation: Critical data or processing parametersor processing parameters
Initial Evaluation: Critical data Initial Evaluation: Critical data or processing parametersor processing parameters
Initial Evaluation: Initial Evaluation: DecisionsDecisions
These results were compared to those obtained previously with the other machines that could be chosen. Then, we decided to buy 3 TRIMA Apheresis systems:
2 for Saint Etienne
1 for Clermont Ferrand
The Installation Qualification/ Operational Qualification confirmed the results of the initial evaluation with similar results for the two machines
Second step : The problem Second step : The problem of plasma needsof plasma needs
France, like many other countries, has an increased need of plasma, essentially for fractionation
We have increased our plasmapheresis activity but we have also searched the different means to obtain more plasma
One of the ways retained was to develop the mixed apheresis collection with the collection of both platelets and plasma. The evaluation started in 2002
The same protocol as in the initial evaluation was performed . We added data of plasma.
Second step : MIXED Second step : MIXED APHERESIS developmentAPHERESIS development
Mean 321,6Max. 430Min. 235Mean 327,53Max. 453Min. 201Mean 0,03Max. 0,11Min. 0,02Mean 9,69Max. 26Min. 0,02
WBC Contamination
(106/unit)Platelets
contamination
(103/mm3)
Plasma volume expected
(TRIMA)(mL)
Plasma volume obtained (mL)
Second step : MIXED Second step : MIXED APHERESIS developmentAPHERESIS development
According to French law requirements:
WBC contamination < 104 leucocytes/unit for fresh frozen plasma
The plasma issued from mixed Apheresis is used in fractionation
Second step : MIXED Second step : MIXED APHERESIS developmentAPHERESIS development
French law requirements:Total Blood volume collected in a donor
must be < to 650mLResults obtained in the evaluation:
Mean: 572.43mL
According to these positive results we decided in 2003 to increase the number of our TRIMA Apheresis systems to 6 units
At the beginning of 2004, 97.3% of our Apheresis platelets processings were mixed Apheresis
2003 Activity2003 Activity
Collection:* 3097 Platelet Apheresis units* 2123 Platelet units from mixed ApheresisTransfusion:1217 concentrates of pooled (5 units) standard platelets4950 Apheresis platelet units--> equivalent to 30854.1011 platelets(We use 0,7.1011 platelets / 10kg )
2004 Activity2004 Activity
From 1/01/2004 to 31/05/2004Collection:* 62 Platelet Apheresis units* 2462 Platelet units from mixed Apheresis Objective for 2004:* 100 Platelet Apheresis units* 6200 Platelet units from mixed Apheresis
Third step : New Third step : New developments developments
Multi component ApheresisMulti component Apheresis
The multi component Apheresis can be the answer to some single or recurrent problems:
Concerning the donors: time needed for donation, possibility to be available, distance from blood centre…Concerning the blood products:
Increase of platelets needsIncrease of red blood cells in some precise blood
groups like O Rhesus negative, O CCDee...
Third step : New Third step : New developments developments
Multi component ApheresisMulti component Apheresis
Double dose Apheresis plateletsIt allows the collection of a minimum of 6.1011
platelets from a single donorFinal results will depend of the initial platelets
count of the donor and of the time of collection but we must have a minimum donor platelets count of 100.103 platelets per mm3 at the end of the processing
Only donors with an initial platelets count of 280.103/mm will be selected.
Among our objectives, we hope to produce an adult unit (4.5 1011) and a paediatric unit (1.5 1011)
Third step : New Third step : New developments developments
Multi component ApheresisMulti component Apheresis
Double dose packed red blood cellsIt allows the collection of 2 units of packed red
cells from the same donorWe must obtain two units with a minimum of
- 225 mL per unit and with a minimum of - 40 g of Hemoglobin per unit and
- a post donation hemoglobin level of 11 gInitial law requirement:
Pre donation Hb level > 13.5g/100 mLFerritin level > 20 ng/mL2 Donations per year
Number of donor will be limited
Third step : New Third step : New developments developments
Multi component ApheresisMulti component Apheresis
Platelets + red blood cellsIt allows the collection of:- One unit of Apheresis platelets and- One packed red cells unit from the same donor
The law requirements are the same than whole blood donation.
You can obtain these 2 products with an increase of collection time of only 10 to 15 ’. It is very short for the donor and better than 2 trips for those leaving far from the Blood Transfusion Centre.
Imminent future: Regional organisation Imminent future: Regional organisation and follow up of platelet apheresis and follow up of platelet apheresis
collectioncollection
Introduction of the VISTA System Objective: regulation of all the activity of
Apheresis platelets collection in all our transfusion area
One medical doctor will be designated as regulatorHe will have access on line to all separator of the region. He will know at any moment the prediction of Apheresis unit under collection and will designate to all centres what is the best program to propose to each donor according to the need of platelets for the patients and the central in reserve