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

Initial Evaluation: Initial Evaluation: DecisionsDecisions

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

ConclusionConclusion