Introduction of « TRIMA » in a Regional Blood Transfusion Organisation Dr Bernard LAMY

1. Introduction of « TRIMA » in a Regional Blood Transfusion Organisation Dr Bernard LAMY

2. The French National Blood Transfusion Establishment

3. The EFS Auvergne Loire 2 University Hospitals: Saint Etienne Clermont Ferrand 6 Regional Hospitals with Blood Banks 3 Cancerology Units with BMT

4. The EFS Auvergne Loire Among the Blood banks 4 of them are concerned by Platelets Collection

5. Initial 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

6. Initial 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

7. Initial 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

8. Initial 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

9. Initial Evaluation

10. Initial Evaluation

11. Initial Evaluation

12. Initial Evaluation: Donors parameters

13. Initial Evaluation: Donors parameters

14. Initial Evaluation: Donors parameters

15. Initial Evaluation: Apheresis platelets parameters 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

16. Initial Evaluation: Apheresis platelets parameters The amount of platelets collected was: Mean : 5.31 1011 platelets / unit +/- 0.85 1011

17. Initial Evaluation: Apheresis platelets parameters

18. Initial Evaluation : Apheresis platelet parameters

19. Initial Evaluation: Critical data or 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

20. Initial Evaluation: Critical data or processing parameters * Donor parameters must be introduced in the TRIMA Computer before starting the process

21. Initial Evaluation: Critical data or 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

22. Initial Evaluation: Critical data or processing parameters

23. Initial Evaluation: Critical data or processing parameters

24. Initial Evaluation: Decisions 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

25. Initial Evaluation: Decisions

26. Second step : The problem of 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.

27. Second step : MIXED APHERESIS development

28. Second step : MIXED APHERESIS 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

29. Second step : MIXED APHERESIS development French law requirements: Total Blood volume collected in a donor must be < to 650mL Results 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

30. 2003 Activity Collection: * 3097 Platelet Apheresis units * 2123 Platelet units from mixed Apheresis Transfusion: 1217 concentrates of pooled (5 units) standard platelets 4950 Apheresis platelet units --> equivalent to 30854.1011 platelets (We use 0,7.1011 platelets / 10kg )

31. 2004 Activity From 1/01/2004 to 31/05/2004 Collection: * 62 Platelet Apheresis units * 2462 Platelet units from mixed Apheresis Objective for 2004: * 100 Platelet Apheresis units * 6200 Platelet units from mixed Apheresis

32. Third step : New developments Multi 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 needs Increase of red blood cells in some precise blood groups like O Rhesus negative, O CCDee...

33. Third step : New developments Multi component Apheresis Double dose Apheresis platelets It allows the collection of a minimum of 6.1011 platelets from a single donor Final 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)

34. Third step : New developments Multi component Apheresis Double dose packed red blood cells It allows the collection of 2 units of packed red cells from the same donor We 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 g Initial law requirement: Pre donation Hb level > 13.5g/100 mL Ferritin level > 20 ng/mL 2 Donations per year Number of donor will be limited

35. Third step : New developments Multi component Apheresis Platelets + red blood cells It 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.

36. Imminent future: Regional organisation and follow up of platelet apheresis collection 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 regulator He 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

37. Conclusion