Transfusion and Apheresis Science 41 (2009) 135–138

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Transfusion and Apheresis Science

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Automated platelet collection using the latest apheresis devices in anIndian setting

Prashant Agarwal *, Anupam VermaDepartment of Transfusion Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI), Lucknow 226014, India

a r t i c l e i n f o

Article history:

1473-0502/$ - see front matter � 2009 Elsevier Ltddoi:10.1016/j.transci.2009.07.013

* Corresponding author.E-mail address: prashant@sgpgi.ac.in (P. Agarwa

a b s t r a c t

In a developing nation like India where there is a scarcity of resources and voluntarydonors, provision of safe and good quality blood and its components is a huge challenge.The demand for platelets is increasing constantly due to better management of variouspatient categories, specifically hemato-oncological cases, where there is an increaseddemand of platelet transfusion. The use of apheresis single donor platelets (SDPs) has beenattributed to increased gap between demand and supply of whole blood derived randomdonor platelets (RDPs). Moreover, the other benefits of SDPs such as decreased donor expo-sure and simplification of inventory management cannot be overlooked.

However, the increased costs and logistic problems, compounded by the lack of aware-ness, limit the donor recruitment and procedures for SDPs. In Indian scenario, there are nospecific guidelines or standards available which can be followed, while simultaneouslyaddressing the associated problems. In this review, we have tried to analyze the variousproblems of donor selection, donor safety and the quality issues regarding plateletpheresis.Based on this we have tried to give certain recommendations which might help the centersin resolving the problems related to plateletpheresis.

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1. Background

The word apheresis is derived from the Greek wordaphaeresis which means ‘‘to separate”, or ‘‘to take awayby force”, or ‘‘to remove”. Hemapheresis is the process ofremoving normal or abnormal blood constituents from cir-culating blood. It can be divided into cytapheresis, the re-moval of the cellular component of blood, orplasmapheresis, removal of the plasma fraction. Cytapher-esis can be selective with removal of the red blood cells(erythrocytapheresis), platelets (plateletpheresis), or leu-kocytes (leukapheresis). Hemapheresis can be performedin both patients (therapeutic) as well as donors.

In a developing country like India, donor plateletphere-sis is the most commonly performed apheresis procedure.The use of apheresis single donor platelets (SDPs) espe-

. All rights reserved.

l).

cially in hemato-oncology patients has been attributed toincreased gap between demand and supply of whole bloodderived random donor platelets (RDPs).

The main benefit of SDP in relation to pooled RDPs ofequivalent dosage is, reduced donor exposure, therebydecreasing risk of transfusion transmitted diseases. Thisdecreased donor exposure has also been shown to delayalloimmunization to HLA. With modern hemapheresisinstruments, the platelet product is also leukocyte reducedduring the collection process. This provides benefits of fur-ther reducing alloimmunization, preventing febrile trans-fusion reactions, and preventing the transmission ofcytomegalovirus infection. An additional advantage ofSDPs over RDPs is simplification of inventory management.

The disadvantages of SDP especially in developingcountry like India is cost and logistic problems likearrangement of ABO group specific donors. In Indian sce-nario it is difficult to recruit donors for apheresis becauseof the longer time and more commitment required for

136 P. Agarwal, A. Verma / Transfusion and Apheresis Science 41 (2009) 135–138

the procedure, compounded by lack of awareness, impro-per knowledge, cultural beliefs, and unknown fears amongdonors.

Therefore in a developing country like India with dearthof voluntary donors, providing safe and quality SDP prod-uct at an affordable cost is a challenging task. We havetried to review all these aspects to provide a meaningfulconclusion. Since there is lack of uniform criteria regardingplateletpheresis donor selection and quality of SDP prod-ucts, we have also tried to review different studies doneon this aspect and their relative contradictions. The needfor this review arose from the fact that we cannot rely ondata from other countries, on account of different physiog-nomic and hematimetric profile of our donors.

2. Donor selection

In our population, ineligibility of donors due to lowplatelet count or hemoglobin concentration was an aggra-vating factor in the already diminished pool of donors. Alarge number of willing donors were deferred falling shortof the acceptance criteria for hemoglobin P12.5 g/dL andplatelet count of P150 � 109/l even after repeated testing[1]. Fourteen percent donors had hemoglobin values belowthe cut-off level, with 62.1% falling in the range of 12.4–11.5 g/dl. Lack of heme iron from the diet with predomi-nantly vegetarian population may explain the prevalenceof low hemoglobin values with or without iron deficientstates [2].

According to Chaudhary et al., owing to the donor lowpre-count, SDP yield of 2 � 1011 per unit recommendedby Council of Europe guidelines was more realistic in In-dian setting compared to American Association of BloodBanks (AABB) recommendation of 3 � 1011 per unit [3].In their study almost 100% SDP units met Council of Europeguidelines against only 40% as per AABB guidelines. How-ever, this was disagreed by Saluja et al., where the authorscited lack of correlation between pre-apheresis donorplatelet count, blood volume processed and collection effi-ciency of cell separator with platelet yield [4]. In their cen-

Table 1Significance of various factors affecting platelet yield.

Author Age Gender

Enein et al. [11] – SChaudhary et al. [7] NS NSGuerrero-Rivera et al. [12] – –Kalish et al. [13] – S

Wt.: weight, Vol. proc.: volume processed, PLT pre-counts: platelet pre-count (d

Table 2Platelet yields: Mean ( � 1011 ± SD) platelet yield with various instruments.

Author CS3000 MCS3p

Chaudhary et al. [8] 2.91 ± 0.75 2.88 ± 0.81Patel et al. [5] 4.05 ± 0.91 5.27 ± 1.48Bueno et al. [14] – –Tenorio et al. [15] 4.3 –

ter 90% of SDP units collected met AABB guidelines.Similarly in other studies around 90% of SDP products wereable to achieve AABB guidelines [5].

3. Quality issues

Correlation between pre-apheresis donor variables withplatelet yield, have also been studied using intermittentflow (MCS3p, Hemonetics) and continuous flow (CS3000,Baxter) cell separators [6,7]. Direct correlation was foundbetween predonation donor platelet count and plateletyield, but no such correlation was found with predonationdonor hemoglobin. Also no correlation was found betweengender, age and weight of donor with yield. Only 9.1% ofdonors with predonation platelet count between 150 and200 � 109/l had yield of >3 � 1011 per unit against 80% ofdonors with predonation platelet count >300 � 109/l. Sim-ilar was the finding of Chaudhary et al. (32.5% versus 80%)[7]. The various factors studied by different researchers aredepicted in Table 1.

Uniform multi-centric studies with larger sample sizeare needed to formulate common guidelines regardingplatelet yield and other quality parameters. Difference ofplatelet yield in different studies can be attributed to var-ied physiognomic and hematimetric profile of donors aswell as variation of methods employed for performingquality control of donor and product parameters. Somereported yields on different machines are presented inTable 2.

The quality of SDP depends on both physiognomicand pre-procedure hematimetric donor variables as wellas principle and collection efficacy of different cell sepa-rators [8]. Even variation in procedure protocol in thesame cell separator can affect platelet yield. PLP protocolof MCS3p gives better platelet yield compared to SDPprotocol [5]. In some of the studies, analyses of proce-dure characterization like venous access, ACD: WB ratio,donation time, procedure time, needle time, etc. wereperformed. These parameters had direct bearing on do-nor safety and comfort [7].

Wt. Vol. proc. Hb PLT pre-counts

S S S SNS – NS S– S S S– – – S

onor), S: significant, NS: non-significant.

MCS+ Amicus Fresenius

2.81 ± 0.72 3.43 ± 1.1 3.08 ± 1.4– – –3.64 ± 0.13 4.24 ± 0.11 –4.0 4.3 –

P. Agarwal, A. Verma / Transfusion and Apheresis Science 41 (2009) 135–138 137

4. Donor safety

The effect of automated plateletpheresis on the hema-tological values of prospective, healthy donors and clinicaloutcome of such hematological alterations were studied byDas et al. [9]. The authors observed significant decrease inpost donation values for hemoglobin, hematocrit, plateletcount and white blood cell count, without any significantchanges in mean platelet volume and platelet distributionwidth. A significant drop in complete blood counts in allthe donors was observed, but none manifested the featuresof thrombocytopenia or anemia. According to the authorsmore prospective studies in this aspect are required whichwould not only ensure establishing guidelines for donorsafety in apheresis but also help in assessing donorsuitability.

Plateletpheresis associated citrate toxicity is usuallyassociated more with intermittent flow cell separators,on account of greater extracorporeal blood volume pro-cessing. However, in one study incidence of citrate toxic-ity was more in continuous flow cell separator (Amicus)as compared to intermittent flow cell separator (MCS3p),though it was not statistically significant [8]. In the samestudy incidence of vasovagal reactions were reported tobe higher with continuous and less with intermittentmachine, though it was not statistically significant. Thereason for higher citrate and vasovagal reactions wasattributed to rapid draw and return rate of citrated bloodto donors undergoing procedure on continuos flowmachine.

Citrate induced biochemical changes in healthy plate-letpheresis donors has also been studied. It was inferredthat citrate induces ionized hypocalcemia and ionizedhypomagnesemia due to chelating effect; however post-procedure there was no significant fall of total calciumand total magnesium [10]. The authors were against rec-ommending prophylactic calcium or magnesium supple-mentation prior to plateletpheresis procedure. However,many transfusion centers continue to provide prophylac-tic calcium supplementation to minimize citrate inducedhypocalcemia. Little information is available regardingmagnesium supplementation in plateletpheresis donors.The quality of plateletpheresis product varied in differentstudies. According to some studies product plateletcount, platelet yield, product volume and collection effi-ciency was found to be significantly higher using PLPprotocol of Hemonetics MCS3p compared to BaxterCS3000 plus and SDP protocol of Hemonetics MCS3p[5]. Contrary to this in one study, product platelet yield,product volume and collection efficiency was not foundto be statistically significantly different in any of the fiveplateletpheresis systems (CS3000 plus, MCS3p, MCS+,Amicus and Fresenius) [8].

There are very few studies in India which have compre-hensively highlighted all aspects of quality control in plate-letpheresis product like pH, residual WBC count, residualRBC count, residual hematocrit other than platelet count,platelet yield and product volume. Of late due to increasedgap in platelet demand few centers in India have alsostarted double dose SDP collection programs and have de-

vised protocol regarding double dose SDP collection whichcan be easily adopted by other centers in developing coun-tries. The authors have recommended donor predonationplatelet count of 250 � 109/l, Hb P 12.5 g/dl and weight> 55 kg as criteria for accepting donors for double doseSDP collection with other criteria similar to single dose col-lection. Target platelet yield P 5.5 � 1011/bag and targetvolume of 400 ml is taken as criteria for splitting SDP fordouble products [9].

5. Recommendations

However more multi-centric studies with larger sam-ple size are needed to draw some conclusion regardingproduct quality and devise common protocol for doubledose SDP collection in India. There is a need for develop-ing standard operating procedure (SOP) for donor plate-letpheresis taking into account our own populationprofile and devising our own guidelines. Based on abovestudies and our own experience we have chalked outfew recommendations:

5.1. Collection of single SDP product

1. Donor selection� Weight > 50 kg.� Hemoglobin P 12.5 g/dl.� Platelet count P 150 � 109/l.� Negative for serological markers of transfusion

transmitted infections (HBV, HCV, HIV, Syphilis,and Malaria).

� ABO/Rh identical with patient.� Normal vitals (Pulse, BP, etc.).� Good accessible veins for phlebotomy.� Rest of donor selection criteria similar to whole

blood donation.

2. Donor and procedure monitoring� Proper installation of apheresis kit as per manufac-

turers’ instructions and program of machine.� Optional pre-procedure calcium prophylaxis.� Donor phlebotomy and predonation sampling for

quality control.� Monitoring of donor and management of donor reac-

tions, if any.� Monitoring of machine for any troubleshooting.� Documentation of procedure parameters at fixed

time intervals.

3. Post-donation protocol� End of procedure as per program of machine.� Post-donation sample from donor and product for

quality control.� Post-donation monitoring and care of donors and

management of donor reactions, if any.� Recording and documentation of final parameters.� Proper labeling and storage of product.

4. Quality control of product� Volume in ml (varies from machine to machine):

approximately 200 ml.� Platelet yield: though depends on predonation vari-

ables of donors, collection efficiency of machine and

138 P. Agarwal, A. Verma / Transfusion and Apheresis Science 41 (2009) 135–138

method employed, but as per our experience targetplatelet yield of >2 � 1011 per unit in 85% of unitsis more realistic in Indian setting.

� Residual WBC level <5 � 106 per unit in 95% prod-ucts if machines with facility of leukodepletion areused.

� Acceptable RBC contamination <2 ml per unit.� Presence of swirling in all products.� pH > 6.2.

5.2. Additional requirements in collection of double SDPproduct

1. Donor selection� Weight P 55 kg.� Platelet count P250 � 109/l.

2. Quality control of product� Volume in ml: approximately 400 ml.� Target platelet yield P5.5 � 1011/bag.� Split product into two halves and label satellite bag,

only when the calculated PLT yield is P5 � 1011 inprimary bag.

6. Conclusion

In nutshell, policies and procedures regarding donorplateletpheresis in India are still under development.Though many studies have been done regarding compari-son of efficacy of different cell separators, only few studiescorrelate donor variables with efficacy of cell separators.Also no studies have been performed regarding instrumentvalidation of different plateletpheresis machines. This val-idation is required to document that a new or modifiedinstrument or technique is capable of consistently produc-ing acceptable products at the production center usingtheir equipment, personnel and cell counting techniques.Instrument validation is the key to formulate standardsfor all transfusion services in India. There is a need to cre-ate awareness in this regard.

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