PMID- 37310606 OWN - NLM STAT- MEDLINE DCOM- 20230713 LR - 20231226 IS - 1496-8975 (Electronic) IS - 0832-610X (Linking) VI - 70 IP - 6 DP - 2023 Jun TI - Sex differences in thromboprophylaxis of the critically ill: a secondary analysis of a randomized trial. PG - 1008-1018 LID - 10.1007/s12630-023-02457-8 [doi] AB - PURPOSE: Venous 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). METHODS: We 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. RESULTS: Critically 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. CONCLUSIONS: We 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. CI - (c) 2023. Canadian Anesthesiologists' Society. FAU - Burns, Karen E A AU - Burns KEA AUID- ORCID: 0000-0002-9967-5424 AD - Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, ON, Canada. AD - Li Ka Shing Knowledge Institute, Unity Health Toronto-St. Michael's Hospital, 30 Bond Street, 4-045 Donnelly Wing, Toronto, ON, M5B 1W8, Canada. AD - Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. FAU - Heels-Ansdell, Diane AU - Heels-Ansdell D AD - Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. FAU - Thabane, Lehana AU - Thabane L AD - Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, ON, Canada. FAU - Kahn, Susan R AU - Kahn SR AD - Department of Medicine, McGill University, Montreal, QC, Canada. FAU - Lauzier, Francois AU - Lauzier F AD - Research Center of the CHU de Quebec-Universite Laval, Population Health and Optimal Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Quebec City, QC, Canada. FAU - Mehta, Sangeeta AU - Mehta S AD - Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, ON, Canada. AD - Mount Sinai Hospital, Toronto, ON, Canada. FAU - Ostermann, Marlies AU - Ostermann M AD - Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas' Hospital, London, UK. FAU - Bhuptani, Pulkit AU - Bhuptani P AD - Department of Pharmacy, Unity Health Toronto-St. Michael's Hospital, Toronto, ON, Canada. FAU - Crowther, Mark A AU - Crowther MA AD - St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, ON, Canada. AD - Department of Medicine, McMaster University, Hamilton, ON, Canada. FAU - Finfer, Simon AU - Finfer S AD - Clinical Trials Unit, The George Institute, Sydney, NSW, Australia. FAU - Cook, Deborah J AU - Cook DJ AD - Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, ON, Canada. AD - Department of Medicine, McMaster University, Hamilton, ON, Canada. CN - PROTECT Investigators, the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group LA - eng PT - Journal Article PT - Randomized Controlled Trial TT - Differences entre les sexes en matiere de thomboprophylaxie chez les patients en etat critique : analyse secondaire d'un essai randomise. DEP - 20230613 PL - United States TA - Can J Anaesth JT - Canadian journal of anaesthesia = Journal canadien d'anesthesie JID - 8701709 RN - 0 (Anticoagulants) RN - 9005-49-6 (Heparin) RN - S79O08V79F (Dalteparin) SB - IM MH - Humans MH - Female MH - Male MH - Anticoagulants/therapeutic use MH - Heparin/therapeutic use MH - Dalteparin/therapeutic use MH - *Venous Thromboembolism/prevention & control/drug therapy MH - Critical Illness MH - Sex Characteristics MH - *Pulmonary Embolism/epidemiology/prevention & control OTO - NOTNLM OT - deep venous thrombosis OT - prophylaxis OT - pulmonary embolism OT - sex differences OT - venous thromboembolism EDAT- 2023/06/13 13:12 MHDA- 2023/07/13 06:42 CRDT- 2023/06/13 11:12 PHST- 2022/03/01 00:00 [received] PHST- 2022/05/30 00:00 [accepted] PHST- 2022/05/27 00:00 [revised] PHST- 2023/07/13 06:42 [medline] PHST- 2023/06/13 13:12 [pubmed] PHST- 2023/06/13 11:12 [entrez] AID - 10.1007/s12630-023-02457-8 [pii] AID - 10.1007/s12630-023-02457-8 [doi] PST - ppublish SO - Can J Anaesth. 2023 Jun;70(6):1008-1018. doi: 10.1007/s12630-023-02457-8. Epub 2023 Jun 13.