Abstract

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 5.0x10(11) PLTs/DP and at least 7.5x10(11) PLTs/TP. The primary endpoint was procedure-related postapheresis PLT count of at least 150x10(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 150x10(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, 10.4x10(9) +/-2.3x10(9) PLTs/min; TP, 10.8x10(9) +/-2.3x10(9) PLTs/min; p<=0.005). The PLT yields were 5.9x10(11) +/-0.8x10(11) PLTs for DP and 8.3x10(11) +/-0.9x10(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. 2012 American Association of Blood Banks.

Abstract

Despite antibiotics, antifungals and haematopoietic growth factors, infections remain a major threat to neutropenic patients. To determine the role of granulocyte transfusions (GTs) in anti-infective therapy during neutropenia, GT administration was randomized in 74 adults with haematological or malignant diseases, febrile neutropenia and pulmonary or soft-tissue infiltrates after conventional or high-dose chemotherapy, a majority of them after allo-SCT (n=39). Neutrophil reconstitution was equal in the treatment and control arm. GT toxicity was minimal. The probability of 28-day survival after randomization was >80% in both groups, and no effect of GT on survival until day 100 could be detected in patients with fungal (n=55), bacterial or unknown infection (n=17) and various levels of neutropenia (ANC <500 vs >500 x 10(6)/l). These findings can be attributed primarily to procedural obstacles, such as long delay from randomization to first GT, low cell content and slow sequence of GT, difficulties in randomizing a safe and potentially life-saving treatment in severely endangered individuals, and a large proportion of rapidly recovering patients in both arms. The requirement of another trial in a more specific patient population with daily transfusions of sufficient numbers of granulocytes to support or refute the empirically acknowledged benefits of GT is discussed.