Hemostatic efficacy of pathogen-inactivated vs untreated platelets: A randomized controlled trial
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], 26 to 11; P 5 .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% CI 22 to 18; P 5 .19 for noninferiority). Transfusion increment parameters were ~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.
|Persistent URL||dx.doi.org/10.1182/blood-2018-02-831289, hdl.handle.net/1765/113985|
van der Meer, P.F, Ypma, P.F, van Geloven, N, van Hilten, J.A. (Joost A.), van Wordragen-Vlaswinkel, R.J. (Rinie J.), Eissen, O. (Okke), … Kerkhoffs, J-L.H. (2018). Hemostatic efficacy of pathogen-inactivated vs untreated platelets: A randomized controlled trial. Blood, 132(2). doi:10.1182/blood-2018-02-831289