Platelet apheresis sometimes causes persistent aggregates (PA). This study (n = 211) shows that changing the apheresis settings to reach fixed product volumes instead of yields does not influence PA incidence, even though PA products on average contain more platelets than controls. Furthermore, logistic regression was used to model if PA can be predicted on the basis of certain predonation parameters. PA donation history was the only parameter retained, proving a strong determinant of predictability [AUC = 0.735 (SE = 0.022)]. Consequently, donations from a donor with previous PA history are 7.8 times more likely to contain PA than from a donor without preceding history

Coene, J

Compernolle, Veerle

Feys, Hendrik

Pottel, H

Vandekerckhove, Philippe

Vandewalle, G

H. B. Feys

H. Pottel

J. Coene

G. Vandewalle

P. Vandekerckhove

V. Compernolle

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Vox Sanguinis

Persistent aggregates in apheresis platelet concentrates are commonly collected from donors with a history of aggregate donation

Ghent University Academic Bibliography

Vox Sanguinis (2016)SHORT REPORT © 2016 The Authors.Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood TransfusionDOI: 10.1111/vox.12437Persistent aggregates in apheresis platelet concentrates arecommonly collected from donors with a history of aggregatedonationH. B. Feys,1 H. Pottel,2 J. Coene,3 G. Vandewalle,3 P. Vandekerckhove3,4,5 & V. Compernolle1,3,41Transfusion Research Center, Belgian Red Cross-Flanders, Ghent, Belgium2Department of Public Health and Primary Care, KU Leuven, KULAK, Kortrijk, Belgium3Blood Service of the Belgian Red Cross-Flanders, Mechelen, Belgium4Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium5Department of Public Health and Primary Care, KU Leuven, Leuven, BelgiumReceived: 15 March 2016,revised 9 June 2016,accepted 30 June 2016Platelet apheresis sometimes causes persistent aggregates (PA). This study(n = 211) shows that changing the apheresis settings to reach fixed product vol-umes instead of yields does not influence PA incidence, even though PA productson average contain more platelets than controls. Furthermore, logistic regressionwas used to model if PA can be predicted on the basis of certain predonationparameters. PA donation history was the only parameter retained, proving astrong determinant of predictability [AUC = 0.735 (SE = 0.022)]. Consequently,donations from a donor with previous PA history are 7.8 times more likely tocontain PA than from a donor without preceding history.Key words: apheresis - donation, Blood collection, Platelet concentrates.IntroductionApheresis procedures may cause platelet aggregation.These generally dissipate, but some persist throughout theentire storage period [1]. Products with persisting aggre-gates (PA) may be quarantined, destroyed or distributedin which case an evaluation procedure can be used as aguideline [2]. Concentrates with PA contain more plateletsthan aggregate-free (AF) ones [3]. Moreover, mildlyincreased storage lesion was observed in PA products ver-sus AF controls [3, 4]. Our previous study included 180donations with PA and an equal number of AF controls.These were collected using an apheresis protocol that pro-jected a fixed platelet yield. However, the introduction ofpathogen inactivation (Intercept, Cerus Corporation, Con-cord, CA) at our blood institute prompted revision of thatparticular protocol to comply with the inclusion criteria.Now, defined volume ranges are projected, resulting in(more) variable platelet yields instead. This raised the fol-lowing questions: Does the new collection protocol influ-ence the incidence of PA? Does it affect the previouslyobserved differences between PA and AF products? Wefurthermore questioned whether the occurrence of PA canbe predicted based on an algorithm containing only pre-donation parameters.Single-donor platelet concentrates were collected byTrima Accel (Terumo BCT) with an inlet to anticoagulant(ACD-A) ratio of 11:1 at an infusion rate of 1.0 ml/min/l ofestimated total blood volume. Additive solution was auto-matically supplemented following donation. Final productvolumes between 300 and 420 ml were projected followingthe Intercept inclusion criteria. In case a larger collectionwas possible, volumes above 610 mL (double collection)were projected to allow splitting to the compliant volumerange. All products were scored for PA presence by trainedstaff according to internal guidelines [2]. The AF group cri-teria were as described [3]. To define whether donors haddonated PA prior to inclusion in this study, historicalrecords of PA incidence were reviewed. These range fromthe start of systematically recording the problem (June2012) until the end of this study period. Statistical analysiswas with SAS (v9.3, SAS Institute Inc, Cary, NC)).Correspondence: Hendrik B. Feys, Belgian Red Cross-Flanders,Transfusion Research Center, Ottergemsesteenweg 413, 9000, Gent,BelgiumE-mail: hendrik.feys@rodekruis.beThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial License,which permits use, distribution and reproduction in any medium, provided the original work is properly cited andis not used for commercial purposes.1The new collection protocol was installed by July 2014,and data collection was between November 2014 and April2015. In that period, 211 donations with PA were registeredon a total of 5664 successful procedures yielding a 3.7%incidence rate, which is not significantly different from theprevious rate [3]. Concurrently, 204 AF controls were col-lected. On average, PA donations were from donors havinghigher circulating platelet counts (274 – 55x103/ll vs.261 – 49x103/ll, Fig. 1a), delivering products with ahigher platelet concentration (1094 – 219x103/ll vs.1041 – 205x103/ll, Fig. 1b). The frequency of single anddouble donations was tabulated, and a significantly highernumber of double donations were found in the PA group(Fig. 1c) confirmed by overall more high-yield products(Fig. 1d) in that arm. This indicates that independent of thecollection protocol, PA incidence is higher in donors withhigh circulating platelet counts. Yet, the absolute differencein mean platelet concentration remains small and distribu-tions overlap, suggesting that this parameter is not suffi-cient to predict the incidence of PA prior to donation.Consequently, we used additional predonation data tobuild a logistic regression model to predict PA donation.Mean platelet volume, gender, whole-blood platelet con-centration, haematocrit, PA donation history, apheresisproduct platelet concentration and volume were includedas variables in a backward-selection logistic regression.Only PA donation history (P < 0.0001) was retained in thefinal model, proving a strong determinant of predictability[AUC = 0.735 (SE = 0.022)]. Based on the odds ratio, adonation from a donor with PA history is thus 7.8 timesmore likely to contain PA than from a donor without pre-ceding history. The other parameters were not substan-tially improving the model. Of note, all 204 donors with aPA donation history (154/211 in the PA, 50/204 in the AFarm) had significantly (P < 0.0001) higher whole-bloodplatelet concentrations (278 – 54x103/ll) than those with-out (257 – 48x103/ll).For blood institutions worldwide, products with PA posea problem. Medical staff performing transfusion arerequired to visually inspect prior to administration in orderto prevent transfusion of aberrantly appearing products. Iftransfusion of PA is tolerated, operators may becomeaccustomed to aberrantly looking products, thus jeopardiz-ing good practice. Moreover, it is not entirely clear whetherPA containing platelet concentrates are safe for transfusionor whether the quality is sufficiently high. These productstherefore often go to waste. At 4% incidence, this wastageis a significant economic cost for (blood) communities. Thecurrent update from our longitudinal survey now showsthat PA history is a strong determinant of future donationswith PA. Our data suggest that this may be caused by theinherent difference in whole-blood platelet concentrationbetween donors. A practical consequence of the higher pla-telet concentration in PA donor’s whole blood is the largerproducts these donors provide, but it is unclear whethercollection of smaller products from such donors would helpdriving back PA incidence. To mitigate PA incidence, pre-vious reports have suggested to increase the anticoagulantto inlet ratio, but additional research is required to confirmutility and investigate the consequences for donor andFig. 1 Donor and donation variables indonations with PA compared to AF controls. (a)Whole-blood platelet concentration of thedonor and (b) platelet concentration in theﬁnal product, following the addition ofadditive solution. Boxes represent median withinterquartile ranges, (+) indicates data mean,and whiskers indicate the 10–90 percentile. (c)The absolute frequency of double-apheresisplatelet concentrates (≥600 ml) is shown bythe hatched bars, while single donations byopen bars. (d) The product platelet yield isshown by plotting all individual data with themedian (line) and interquartile ranges(whiskers) embedded.© 2016 The Authors.Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood TransfusionVox Sanguinis (2016)2 H. B. Feys et al.operators [1, 5]. With the adoption of Intercept pathogeninactivation, PA have disappeared in our blood institution.This can be attributed to the additional filtration in theIntercept pathogen inactivation process which is intendedto remove putative compound adsorption device beads butcoincidently retains platelet aggregates. Therefore, themere visual aspect of PA in Intercept-treated products is nolonger preventing product issuance. However, removal ofaggregates does not necessarily guarantee that the (small)increase in storage lesion observed in products with PA[3, 4] will normalize.AcknowledgementsWe thank Rosalie Devloo, Dorien De Clippel, LeenVan Heddegem and Dr. Karen De Pourcq for datacollection and technical assistance. This research wassupported by the Foundation for Research andDevelopment of the Belgian Red Cross-Flanders BloodService.Author contributionsHBF designed and managed research, performed experi-ments, interpreted data and wrote the manuscript; HPdesigned research, performed statistical analysis andinterpreted data; GV, JC, PV provided essential raw dataand interpreted data; VC conceptualized, designed andmanaged research and interpreted data. All authors criti-cally reviewed the manuscript.References1 Ringwald J, Antoon M, Eckstein R,et al.: Residual aggregates in plateletproducts: what do we know? Vox Sang2014; 106:209–2182 van der Meer PF, Dumont LJ, LozanoM, et al.: Aggregates in platelet concen-trates. Vox Sang 2015; 108:96–1003 Feys HB, Coene J, Devloo R, et al.: Persis-tent aggregates in apheresis platelet con-centrates. Vox Sang 2015; 108:368–3774 Feys HB, Van Aelst B, Devloo R, et al.:The contribution of von Willebrand fac-tor-GPIbalpha interactions to persistentaggregate formation in apheresisplatelet concentrates. Vox Sang 2016;110:344–3515 Douglas C, Cardenas C, Mills AE: Riskvs. reward: setting the anticoagulantratio to maximize platelet collectionsand mitigate aggregates. Transfusion2012; 52:242A© 2016 The Authors.Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood TransfusionVox Sanguinis (2016)Aggregate recurrence in platelet donors 3

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Persistent aggregates in apheresis platelet concentrates are commonly collected from donors with a history of aggregate donation

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