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Donor safety in triple plateletpheresis: results from the German and Austrian Plateletpheresis Study Group multicenter trial
Author(s) -
Heuft HansGert,
Moog Rainer,
Fischer Eike G.,
Zingsem Jürgen
Publication year - 2013
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2012.03714.x
Subject(s) - plateletpheresis , medicine , apheresis , platelet , adverse effect
BACKGROUND: The objective was to investigate potential risks for apheresis donors associated with a triple‐plateletpheresis (TP) program. STUDY DESIGN AND METHODS: Eleven hemapheresis centers randomly assigned 411 repeat donors (ratio, 1:1.2) to either double plateletpheresis (DP; 185 donors) or TP (226 donors) with a platelet (PLT) target content of at least 5.0 × 10 11 PLTs/DP and at least 7.5 × 10 11 PLTs/TP. The primary endpoint was procedure‐related postapheresis PLT count of at least 150 × 10 9 /L (probability, ≥98%). Secondary endpoints were apheresis characteristics and donor adverse reactions. RESULTS: In 6 of 1133 DPs (0.5%) in 4 of 185 donors (2.2%) and in 20 of 1020 TPs (2.0%) in 14 of 226 donors (6.2%), postapheresis PLT counts were below 150 × 10 9 /L. There were marginal but significant differences in collection efficiency (DP, 69.2 ± 9.1%; TP, 70.9 ± 9.0%; p ≤ 0.0001) and collection rate (DP, 10.4 × 10 9 ± 2.3 × 10 9 PLTs/min; TP, 10.8 × 10 9 ± 2.3 × 10 9 PLTs/min; p ≤ 0.005). The PLT yields were 5.9 × 10 11 ± 0.8 × 10 11 PLTs for DP and 8.3 × 10 11 ± 0.9 × 10 11 PLT for TP (p ≤ 0.0001) at processing times of 59 ± 13 minutes (DP) versus 80 ± 16 minutes (TP; p ≤ 0.0001). Significant PLT recruitment (1.10 ± 0.14 vs. 1.20 ± 0.23; p < 0.0001) was seen for both DP and TP. DP and TP did not differ with regard to venous access problems (VAPs) without discontinuation (3.8% for both), but DP induced fewer VAPs with discontinuation (1.1% vs. 3.0%; p < 0.01). Mild citrate toxicity (1.7% vs. 3.9%; p < 0.01) and circulatory reactions (0.4% vs. 2.2%; p < 0.01) were more often noticed in TP, but caused no increase in discontinuations. CONCLUSIONS: TP results in an increase in mild donor reactions but does not significantly impair donor safety or product quality.