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

Center for Clinical Transfusion Research, Sanquin, Leiden, Netherlands; p.vandermeer@sanquin.nl. Department of Hematology, HagaZiekenhuis, The Hague, Netherlands. Dept. of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands. Center for Clinical Transfusion Research, Sanquin, Leiden, Netherlands. Department of Immunohematology and Blood bank, Leiden University Medical Center, Leiden, Netherlands. Department of Hematology, HagaZiekenhuis, The Hague, Netherlands. Department of Immunohematology and Blood bank, Leiden University Medical Center, Leiden, Netherlands. Juravinsky Hospital, Hamilton, Canada. Hematology, Maastricht University Medical Center, Maastricht, Netherlands. Hematology, Erasmus Medical Center, Rotterdam, Netherlands. Ottawa Hospital, Ottawa, Canada. Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. Department of Medicine, Division of Hematology, London Health Sciences Center, London, ON, Canada. Kingston General Hospital, Kingston, Canada. Immunology, Blood Systems Research Institute, San Francisco, CA, United States. Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, United States. Center for Clinical Transfusion Research, Sanquin, Leiden, Netherlands. Haukeland University Hospital, Bergen, Norway. Medicine, McMaster University, Hamilton, ON, Canada. Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands. Department of Hematology, HagaZiekenhuis, The Hague, Netherlands.

Blood. 2018;132((2):):223-231
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Abstract
Pathogen inactivation of platelet concentrates reduces the risk of 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 ultraviolet B illumination technology (intervention) compared to 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 (WHO) 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 bleeding in the intention-to-treat analysis: 51% of the transfusion treatment periods in the control arm and 54% in the intervention arm (95% CI -6 to 11, p-value for noninferiority 0.012). In the per-protocol analysis, however, difference in grade ≥ 2 bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI -2 to 18, p-value for noninferiority 0.19). Transfusion increment parameters were about 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. (The Netherlands National Trial Registry number: NTR2106).
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Language : English
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine