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

The French National Blood Transfusion Establishment

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

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

Initial Evaluation 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

Initial Evaluation 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

Initial Evaluation Initial Evaluation Our 3 main objectives were to - Obtain a minimum of 3.5 to 4x10 11 platelets per Apheresis Platelet concentrates - Obtain Apheresis Platelet concentrates in accordance with law requirements - Limit the time of collection for donor conveniences

Initial Evaluation 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

Initial Evaluation Initial Evaluation

Initial Evaluation: Donors parameters

Initial Evaluation: Apheresis platelets parameters The French law requirement is, for the donor, a minimum of Plts after donation In all the processing, the post donation platelets count was over this value

Initial Evaluation: Apheresis platelets parameters The amount of platelets collected was: Mean : platelets / unit +/

Initial Evaluation: Apheresis platelets parameters

Initial Evaluation : Apheresis platelet parameters

Initial Evaluation: Critical data or processing parameters * Blood donor initial platelets count: must be > / mm 3 * 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 or processing parameters * Donor parameters must be introduced in the TRIMA Computer before starting the process

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

Initial Evaluation: Critical data or processing parameters

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

Initial Evaluation: Decisions

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.

Second step : MIXED APHERESIS development

According to French law requirements: WBC contamination < 10 4 leucocytes/unit for fresh frozen plasma The plasma issued from mixed Apheresis is used in fractionation

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: mL 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 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 platelets (We use 0, platelets / 10kg )

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

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...

Third step : New developments Multi component Apheresis Double dose Apheresis platelets It allows the collection of a minimum of 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 platelets per mm 3 at the end of the processing Only donors with an initial platelets count of /mm will be selected. Among our objectives, we hope to produce an adult unit ( ) and a paediatric unit ( )

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 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

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.

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

Conclusion