학술논문
Efficacy of UVC-treated, pathogen-reduced platelets versus untreated platelets: a randomized controlled non-inferiority trial.
Document Type
Academic Journal
Author
Brixner V; German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main.; Bug G; Department of Hematology and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt/Main.; Pohler P; German Red Cross Blood Service NSTOB, Springe.; Krämer D; Department of Oncology and Hematology, University Hospital, Oldenburg.; Metzner B; Department of Oncology and Hematology, University Hospital, Oldenburg.; Voss A; Department of Oncology and Hematology, University Hospital, Oldenburg.; Casper J; Department of Oncology and Hematology, University Hospital, Oldenburg.; Ritter U; Department of Hematology and Oncology, Municipal Hospital Bremen, Bremen.; Klein S; Department of Hematology and Oncology, University Hospital, Mannheim.; Alakel N; Medical Clinic I, Department of Hematology and Oncology, University Hospital, Carl Gustav Carus Faculty of Medicine, Dresden.; Peceny R; Department of Hematology and Oncology, Municipal Hospital, Osnabrück.; Derigs HG; Department of Hematology and Oncology, Municipal Hospital Frankfurt-Hoechst, Frankfurt/Main.; Stegelmann F; Department of Internal Medicine III, University Hospital, Ulm.; Wolf M; Department of Hematology and Oncology, Municipal Hospital, Kassel.; Schrezenmeier H; Institute for Transfusion Medicine, University Hospital Ulm, Ulm, Germany; and Institute for Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Service Baden-Württemberg - Hessia, Ulm.; Thiele T; Institute for Immunology and Transfusion Medicine, University Medicine, Greifswald.; Seifried E; German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main.; Kapels HH; German Red Cross Blood Service NSTOB, Oldenburg.; Döscher A; German Red Cross Blood Service NSTOB, Oldenburg.; Petershofen EK; German Red Cross Blood Service NSTOB, Oldenburg.; Müller TH; German Red Cross Blood Service NSTOB, Springe.; Seltsam A; German Red Cross Blood Service NSTOB, Springe, Germany; Bavarian Red Cross Blood Service, Nuremberg. a.seltsam@blutspendedienst.com.
Source
Publisher: Ferrata Storti Foundation Country of Publication: Italy NLM ID: 0417435 Publication Model: Electronic Cited Medium: Internet ISSN: 1592-8721 (Electronic) Linking ISSN: 03906078 NLM ISO Abbreviation: Haematologica Subsets: MEDLINE
Subject
Language
English
Abstract
Pathogen reduction (PR) technologies for blood components have been established to reduce the residual risk of known and emerging infectious agents. THERAFLEX UVPlatelets, a novel UVC light-based PR technology for platelet concentrates, works without photoactive substances. This randomized, controlled, double-blind, multicenter, noninferiority 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. 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 perprotocol analyses were 18.2% (95% confidence interval [CI]: 6.4%; 30.1) and 18.7% (95% CI: 6.3%; 31.1%), respectively. 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 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 technology is safe but non-inferiority was not demonstrated. (The German Clinical Trials Register number: DRKS00011156).