• BurnsKaren E AKEA0000-0002-9967-5424Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, ON, Canada.Li Ka Shing Knowledge Institute, Unity Health Toronto-St. Michael's Hospital, 30 Bond Street, 4-045 Donnell, Diane Heels-Ansdell, Lehana Thabane, Susan R Kahn, Francois Lauzier, Sangeeta Mehta, Marlies Ostermann, Pulkit Bhuptani, Mark A Crowther, Simon Finfer, Deborah J Cook, and PROTECT Investigators, the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group.
• Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, ON, Canada.
• Can J Anaesth. 2023 Jun 1; 70 (6): 100810181008-1018.

PurposeVenous thromboembolism (VTE) is a common complication of critical illness. Sex- or gender-based analyses are rarely conducted and their effect on outcomes is unknown. We assessed for an effect modification of thromboprophylaxis (dalteparin or unfractionated heparin [UFH]) by sex on thrombotic (deep venous thrombosis [DVT], pulmonary embolism [PE], VTE) and mortality outcomes in a secondary analysis of the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT).MethodsWe conducted unadjusted analyses using Cox proportional hazards analysis, stratified by centre and admission diagnostic category, including sex, treatment, and an interaction term. Additionally, we performed adjusted analyses and assessed the credibility of our findings.ResultsCritically ill female (n = 1,614) and male (n = 2,113) participants experienced similar rates of DVT, proximal DVT, PE, any VTE, ICU death, and hospital death. In unadjusted analyses, we did not find significant differences in treatment effect favouring males (vs females) treated with dalteparin (vs UFH) for proximal leg DVT, any DVT, or any PE, but found a statistically significant effect (moderate certainty) favouring dalteparin in males for any VTE (males: hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.52 to 0.96 vs females: HR, 1.16; 95% CI, 0.81 to 1.68; P = 0.04). This effect remained after adjustment for baseline characteristics (males: HR, 0.70; 95% CI, 0.52 to 0.96 vs females: HR, 1.17; 95% CI, 0.81 to 1.68; P = 0.04) and weight (males: HR, 0.70; 95% CI, 0.52 to 0.96 vs females: HR, 1.20; 95% CI, 0.83 to 1.73; P = 0.03). We did not identify a significant effect modification by sex on mortality.ConclusionsWe found an effect modification by sex of thromboprophylaxis on VTE in critically ill patients that requires confirmation. Our findings highlight the need for sex- and gender-based analyses in acute care research.© 2023. Canadian Anesthesiologists' Society.

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