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Ferrata Storti Foundation
Haematologica 2021 Volume 106(4):1086-1096
Blood Transfusion
Efficacy of UVC-treated, pathogen-reduced platelets versus untreated platelets: a randomized controlled non-inferiority trial
Veronika Brixner,1* Gesine Bug,2* Petra Pohler,3* Doris Krämer,4
Bernd Metzner,4 Andreas Voß,4 Jochen Casper,4 Ulrich Ritter,5 Stefan Klein,6 Nael Alakel,7 Rudolf Peceny,8 Hans G. Derigs,9 Frank Stegelmann,10
Martin Wolf,11 Hubert Schrezenmeier,12 Thomas Thiele,13 Erhard Seifried,1 Hans-Hermann Kapels,14 Andrea Döscher,14 Eduard K. Petershofen,14 Thomas H. Müller3 and Axel Seltsam3,15
1German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main; 2Department of Hematology and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt/Main; 3German Red Cross Blood Service NSTOB, Springe; 4Department of Oncology and Hematology, University Hospital, Oldenburg; 5Department of Hematology and Oncology, Municipal Hospital Bremen, Bremen; 6Department of Hematology and Oncology, University Hospital, Mannheim; 7Medical Clinic I, Department of Hematology and Oncology, University Hospital, Carl Gustav Carus Faculty of Medicine, Dresden; 8Department of Hematology and Oncology, Municipal Hospital, Osnabrück; 9Medical Clinic I, Department of Hematology and Oncology, Carl Gustav Carus Faculty of Medicine, University Hospital, Dresden; 10Department of Internal Medicine III, University Hospital, Ulm; 11Department of Hematology and Oncology, Municipal Hospital, Kassel; 12Institute for Transfusion Medicine, University Hospital Ulm, Ulm; and Institute for Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Service Baden-Württemberg - Hessia, Ulm; 13Institute for Immunology and Transfusion Medicine, Department of Medicine, University of Greifswald, Greifswald; 14German Red Cross Blood Service NSTOB, Oldenburg and 15Bavarian Red Cross Blood Service, Nuremberg, Germany
*VB, GB and PP contributed equally as co-first authors
ABSTRACT
Pathogen reduction (PR) technologies for blood components have been established to reduce the residual risk of known and emerging infectious agents. THERAFLEX UV-Platelets, a novel ultraviolet C (UVC) light-based PR technology for platelet concentrates, works with- out photoactive substances. This randomized, controlled, double-blind, multicenter, non-inferiority trial was designed to compare the efficacy and safety of UVC-treated platelets to that of untreated platelets in thrombocytopenic patients with hematologic-oncologic diseases. The primary objective was to determine non-inferiority of UVC-treated platelets, assessed by the 1-hour corrected count increment (CCI) in up to eight per-protocol platelet transfusion episodes. Analysis of the 171 eligible patients showed that the defined non-inferiority margin of 30% of UVC-treated platelets was narrowly missed as the mean differences in 1-hour CCI between standard platelets versus UVC-treated platelets for intention-to-treat and per-protocol analyses were 18.2% (95% Confidence Interval [CI]: 6.4-30.1) and 18.7% (95% CI: 6.3-31.1), respec- tively. In comparison to the control, the UVC group had a 19.2% lower mean 24-hour CCI and was treated with an about 25% higher number of platelet units, but the average number of days to the next platelet transfusion did not differ significantly between both treatment groups. The frequency of low-grade adverse events was slightly higher in the UVC group and the frequencies of refractoriness to platelet transfusion, platelet alloimmunization, severe bleeding events, and red blood cell transfusions were comparable between groups. Our study suggests that transfusion of pathogen-reduced platelets produced with the UVC tech- nology is safe but non-inferiority was not demonstrated. (clinicaltrials gov. Identifier: DRKS00011156).
Correspondence:
AXEL SELTSAM
a.seltsam@blutspendedienst.com
Received: May 26, 2020. Accepted: November 6, 2020. Pre-published: February 4, 2021.
https://doi.org/10.3324/haematol.2020.260430
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