The French National Blood Transfusion Establishment

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Introduction of  TRIMA  in a Regional Blood
Transfusion Organisation Dr Bernard LAMY
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The French National Blood Transfusion
Establishment
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The EFS Auvergne Loire
2 University Hospitals Saint Etienne
Clermont Ferrand 6 Regional Hospitals with
Blood Banks 3 Cancerology Units with BMT
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The EFS Auvergne Loire

Among the Blood banks 4 of them are
concerned by Platelets Collection
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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
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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
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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
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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
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Initial Evaluation


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Initial Evaluation


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Initial Evaluation


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Initial Evaluation Donors parameters


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Initial Evaluation Donors parameters


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Initial Evaluation Donors parameters


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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
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Initial Evaluation Apheresis platelets
parameters


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


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Initial Evaluation Apheresis platelet parameters






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Initial Evaluation Critical data or processing
parameters

Blood donor initial platelets count must be gt
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 lt
50 kg

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Initial Evaluation Critical data or processing
parameters

Donor parameters must be introduced in the
TRIMA Computer before starting the process

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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

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Initial Evaluation Critical data or processing
parameters



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Initial Evaluation Critical data or processing
parameters



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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

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Initial Evaluation Decisions



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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.

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Second step MIXED APHERESIS development



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Second step MIXED APHERESIS development



According to French law requirements WBC
contamination lt 104 leucocytes/unit for fresh
frozen plasma The plasma issued from mixed
Apheresis is used in fractionation
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Second step MIXED APHERESIS development
French law requirements Total Blood volume
collected in a donor must be lt 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
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2003 Activity
Collection 3097 Platelet Apheresis units
2123 Platelet units from mixed Apheresis Transfusi
on 1217 concentrates of pooled (5 units)
standard platelets 4950 Apheresis platelet
units --gt equivalent to 30854.1011 platelets (We
use 0,7.1011 platelets / 10kg )




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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




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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...




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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)




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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 gt 13.5g/100 mL Ferritin
level gt 20 ng/mL 2 Donations per year Number of
donor will be limited




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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.




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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




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Conclusion