Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction.

Pathogen reduction (PR) of platelet products increases costs and available clinical studies are equivocal with respect to clinical and haemostatic effectiveness. We conducted a multicentre, open-label, randomized, non-inferiority trial comparing the clinical effectiveness of buffy-coat derived leukoreduced platelet concentrates (PC) stored for up to 7 d in plasma with platelets stored in platelet additive solution III (PASIII) without and with treatment with amotosalen-HCl/ultraviolet-A (UVA) photochemical pathogen reduction (PR-PASIII). Primary endpoint of the study was 1-h corrected count increment (CCI). Secondary endpoints were 24-h CCI, bleeding, transfusion requirement of red cells and PC, platelet transfusion interval and adverse transfusion reactions. Compared to plasma-PC, in the intention to treat analysis of 278 evaluable patients the mean difference for the 1-h CCI of PR-PASIII-PC and PASIII-PC was -31% (P < 0.0001) and -9% (P = n.s.), respectively. Twenty-seven patients (32%) had bleeding events in the PR-PASIII arm, as compared to 19 (19%) in the plasma arm and 14 (15%) in the PASIII arm (P = 0.034). Despite the potential advantages of pathogen (and leucocyte) inactivation of amotosalen-HCl/UVA-treated platelet products, their clinical efficacy is inferior to platelets stored in plasma, warranting a critical reappraisal of employing this technique for clinical use.

Performance of a novel test to quantify activated protein C resistance in women with a history of pre-eclampsia.

OBJECTIVE: We determined the performance of a functional test for activated protein C (APC) resistance in formerly pre-eclamptic women and matched controls. STUDY DESIGN: In our university medical center, we assessed the response to APC in plasma in 118 formerly pre-eclamptic women and in 57 healthy controls, we measured plasma levels of thrombophilic factors and we performed statistical analysis. RESULTS: The incidence of APC resistance was significantly higher in formerly pre-eclamptics than in controls. Formerly APC resistant pre-eclamptics more often experienced intra-uterine growth restriction (IUGR) than their non-APC resistant counterparts. CONCLUSION: APC resistance determined by this functional test is present in a large subgroup of formerly pre-eclamptics. A higher incidence of IUGR in this group suggests a more severe course of the experienced pregnancy complications. Additional study is needed to determine whether this test is sensitive in predicting recurrence of pre-eclampsia or IUGR.