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Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial

Pieter F. van der Meer, Paula F. Ypma, Nan van Geloven, Joost A. van Hilten, Rinie J. van Wordragen-Vlaswinkel, Okke Eissen, Jaap J. Zwaginga, Michael Trus, Erik A. M. Beckers, Peter te Boekhorst, Alan Tinmouth, Yulia Lin, Cyrus Hsia, David Lee, Philip J. Norris, Raymond P. Goodrich, Anneke Brand, Tor Hervig, Nancy M. Heddle, Johanna G. van der Bom and Jean-Louis H. Kerkhoffs

Key Points

  • Pathogen-inactivated platelets were noninferior in preventing bleeding only in intention-to-treat analysis.

  • In contrast to animal models, alloimmunization could not be prevented when using pathogen-inactivated platelets.

Publisher's Note: There is a Blood Commentary on this article in this issue.

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% CI −2 to 18; P = .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.

  • Submitted February 2, 2018.
  • Accepted April 25, 2018.
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