Scientific Publications Database

Article Title: Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial
Authors: van der Meer, Pieter F.; Ypma, Paula F.; van Geloven, Nan; van Hilten, Joost A.; van Wordragen-Vlaswinkel, Rinie J.; Eissen, Okke; Zwaginga, Jaap J.; Trus, Michael; Beckers, Erik A. M.; te Boekhorst, Peter; Tinmouth, Alan; Lin, Yulia; Hsia, Cyrus; Lee, David; Norris, Philip J.; Goodrich, Raymond P.; Brand, Anneke; Hervig, Tor; Heddle, Nancy M.; van der Bom, Johanna G.; Kerkhoffs, Jean-Louis H.
Journal: BLOOD Volume 132 Issue 2
Date of Publication:2018
Abstract:
Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; P=.012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI22 to 18; P=.19 for noninferiority). Transfusion increment parameters were similar to 50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as # NTR2106 and at www. clinicaltrials. gov as # NCT02783313.