Interpatient variability Akt inhibitor was further complicated by the variability of the response to transfusions in a single patient; interpretation of a study becomes more complex when randomization occurs at the patient level and not at the transfusion level. Lozano et al. limited their assessment to one transfusion in order to reduce this effect [76]. It is also noteworthy that only the Janetzko study [74] formally defined the incidence of bacterial contamination as a secondary outcome, although the frequency of this complication was at an order of

magnitude beyond the predictive power of these studies. The first RCT of PI-treated PCs, published in 2003, was the euroSPRITE trial [79], which compared 103 patients who received PC prepared from buffy INCB024360 price coats. The PCs were either treated or untreated with amotosalen/UVA (311 and 256 transfusions, respectively),

and the transfusion results were monitored over a time period of 56 days. The CCI was not significantly different between the two groups (13.100 ± 5.400 vs. 14.900 ± 6.200, respectively). Secondary outcomes (i.e., number of platelet transfusions per patient, occurrence of bleeding, number of RBCs transfused, development of a refractory state, and TR rate) also did not differ between the two groups. The SPRINT trial [77] included 645 patients and was published in 2004. The primary outcome was the occurrence of grade 2 bleeding (WHO classification) during a follow-up period of 28 days; platelets were obtained through apheresis. The occurrence of grade 2 bleeding in the amotosalen/UVA-treatment arm was 58.5%, versus 57.5% in the control group. The occurrence of grade 3 or 4 bleeding was 4.1% and 6.1% in the amotosalen/UVA-treated and control groups, respectively. No statistically

significant difference was observed. In contrast with the results of the euroSPRITE trial, CCIs were lower in the recipients of PI-treated PCs compared to controls (11.1 versus 16.0), and the former group received more transfusions (8.4 vs. 6.2 per patient). It should, however, be noted that the platelet content was lower in the treatment group else than in the control group (3.7 × 1011 vs. 4.0 × 1011/unit). In Janetzko et al.’s study [74], a commercially available kit for amotosalen/UVA treatment was used, which reduced the number of preparation steps and limited the platelet loss. Their RCT of 43 patients revealed a decrease (although not statistically significant) in CCI after the transfusion of apheresis platelets treated with amotosalen/UVA (11.600 ± 7.300 vs. 15.100 ± 6.400), confirming the results of the SPRINT trial. However, the standard platelets were stored in 100% plasma, whereas the amotosalen/UVA-treated platelets were resuspended in a mixture of plasma and platelet additive solution III (PAS III) [74].