Transcript The French National Blood Transfusion Establishment

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
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
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
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 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
Number of donors:
290 Men
168 Women
Siz e (meter)
Body weight (kg)
Total Blood
volume (liter)
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
1,72
1,96
1,48
75
118
50
4,722
7,04
3,091
Initial Evaluation
Blood volume
processed (liter)
Equivalent Total
Blood Volume
Blood Flow
(mL/min)
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
3,88
5,489
3,005
0,93
1,24
0,67
50
66
33
Initial Evaluation
Mean
473
Anticoagulant
Max.
661
Volume used (mL)
Min.
334
Mean 7/64=0,109
Anticoagulant Ratio Max. 4/23=0,174
Min. 3/40=0,075
Mean
87
Collection time
Max.
119
(min)
Min.
61
Initial Evaluation:
Donors parameters
Before platelets collection
Mean
Hemoglobin
Max.
(g/100mL)
Min.
Mean
Hematocrit
Max.
Min.
Red Cell Volum Mean
Max.
3
(µ )
Min.
15
18
11,6
43
52,4
33,3
88
98,6
86,2
After
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
14,1
17,2
11,2
41,6
49,1
31
88,3
98,3
86,9
Initial Evaluation:
Donors parameters
Before platelets collection
Mean
Leucocytes
Max.
3
3
(10 /mm )
Min.
Mean
Polynuclear cells
Max.
(% )
Min.
Mean
Lymphocytes (% ) Max.
Min.
6,64
11,4
3,37
56
78,1
47,1
32
54,4
14,2
After
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
6,89
11,8
3,1
52,8
81,3
27
35,2
58,3
10,4
Initial Evaluation:
Donors parameters
Before platelets collection
Mean
3
3
Platelets (10 /mm ) Max.
Min.
Mean
Platelets volume Max.
Min.
260
442
176
7,66
11,7
5,7
TRIMA Donor's post count
After
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
176
327
121
8,11
12,3
6,2
154
455
104
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
Initial Evaluation:
Apheresis platelets parameters
The amount of platelets collected was:
Mean : 5.31 1011 platelets / unit
+/- 0.85 1011
Initial Evaluation:
Apheresis platelets parameters
pH at J0
pH at J2
pH at J4
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
7.38
7.59
6.98
7.28
7.37
6.83
7.02
7.11
6.65
Initial Evaluation : Apheresis
platelet parameters
Leucocytes
contamination
Mean
0,065
Max.
0,473
6
3
Min.
0,002
(WBC10 /mm )
Leucocytes
Mean
0,0584
contamination
Max.
0,731
(WBC106/unit)
Min.
0,0009
Law requirements:
< 1.106 wbc/unit
All the apheresis platelets were in
accordance
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
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: 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
Plasma volume
expected
(TRIMA)(mL)
Plasma volume
obtained (mL)
WBC
Contamination
(106/unit)
Platelets
contamination
(103/mm3)
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
Mean
Max.
Min.
321,6
430
235
327,53
453
201
0,03
0,11
0,02
9,69
26
0,02
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
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
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 )
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 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)
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
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