title: Donor safety in triple plateletpheresis: results from the German and Austrian Plateletpheresis Study Group multicenter trial.
abstract: BACKGROUND
  The objective was to investigate potential risks for apheresis donors associated with a triple-plateletpheresis (TP) program.
  
  
  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.
authors.affiliation: Institute for Transfusion Medicine, Hannover Medical School, Hannover, Germany. heuft.hansgert@mh-hannover.de.
authors.forename: Hans-Gert
authors.initials: HG
authors.lastname: Heuft
authors.forename: Rainer
authors.initials: R
authors.lastname: Moog
authors.forename: Eike G
authors.initials: EG
authors.lastname: Fischer
authors.forename: Jürgen
authors.initials: J
authors.lastname: Zingsem
mesh_terms: D000328:Adult; D001317:Austria; D001782:Blood Donors; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010983:Plateletpheresis / Q000009:adverse effects*