• N. Engl. J. Med. · Apr 2023

    Randomized Controlled Trial Multicenter Study

    Effect of Donor Sex on Recipient Mortality in Transfusion.

    • Michaël Chassé, Dean A Fergusson, Alan Tinmouth, Jason P Acker, Iris Perelman, Angie Tuttle, Shane W English, Steven Hawken, Alan J Forster, Nadine Shehata, Kednapa Thavorn, Kumanan Wilson, Nancy Cober, Heather Maddison, and Melanie Tokessy.
    • From the Department of Medicine, Centre Hospitalier de l'Université de Montréal, and the Department of Medicine, Faculty of Medicine, and the School of Public Health, Université de Montréal, Montreal (M.C.), the Clinical Epidemiology Program, Ottawa Hospital Research Institute (D.A.F., A. Tinmouth, I.P., A. Tuttle, S.W.E., S.H., A.J.F., K.T.), the Department of Medicine (D.A.F., A. Tinmouth, S.W.E., A.J.F., K.W.), and the School of Epidemiology and Public Health (D.A.F., S.H., K.T., K.W.), University of Ottawa, Canadian Blood Services (D.A.F., A. Tinmouth, J.P.A.), Bruyère Research Institute (K.W.), and the Ottawa Hospital (N.C., H.M., M.T.), Ottawa, the Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton (J.P.A.), and ICES (formerly the Institute for Clinical Evaluative Sciences) (S.H., A.J.F., K.T.), the Dalla Lana School of Public Health and the Department of Medicine, University of Toronto (N.S.), and the Department of Medicine, University Health Network (N.S.), Toronto - all in Canada.
    • N. Engl. J. Med. 2023 Apr 13; 388 (15): 138613951386-1395.

    BackgroundConflicting observational evidence exists regarding the association between the sex of red-cell donors and mortality among transfusion recipients. Evidence to inform transfusion practice and policy is limited.MethodsIn this multicenter, double-blind trial, we randomly assigned patients undergoing red-cell transfusion to receive units of red cells from either male donors or female donors. Patients maintained their trial-group assignment throughout the trial period, including during subsequent inpatient and outpatient encounters. Randomization was conducted in a 60:40 ratio (male donor group to female donor group) to match the historical allocation of red-cell units from the blood supplier. The primary outcome was survival, with the male donor group as the reference group.ResultsA total of 8719 patients underwent randomization before undergoing transfusion; 5190 patients were assigned to the male donor group, and 3529 to the female donor group. At baseline, the mean (±SD) age of the enrolled patients was 66.8±16.4 years. The setting of the first transfusion was as an inpatient in 6969 patients (79.9%), of whom 2942 (42.2%) had been admitted under a surgical service. The baseline hemoglobin level before transfusion was 79.5±19.7 g per liter, and patients received a mean of 5.4±10.5 units of red cells in the female donor group and 5.1±8.9 units in the male donor group (difference, 0.3 units; 95% confidence interval [CI], -0.1 to 0.7). Over the duration of the trial, 1141 patients in the female donor group and 1712 patients in the male donor group died. In the primary analysis of overall survival, the adjusted hazard ratio for death was 0.98 (95% CI, 0.91 to 1.06).ConclusionsThis trial showed no significant difference in survival between a transfusion strategy involving red-cell units from female donors and a strategy involving red-cell units from male donors. (Funded by the Canadian Institutes of Health Research; iTADS ClinicalTrials.gov number, NCT03344887.).Copyright © 2023 Massachusetts Medical Society.

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