Sex differences in thromboprophylaxis of the critically ill: a secondary analysis of a randomized trial

Burns, KEA; Heels-Ansdell, D; Thabane, L; Kahn, SR; Lauzier, F; Mehta, S; Ostermann, M; Bhuptani, P; Crowther, MA; Finfer, S; Cook, DJ; PROTECT Investigators, the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group

doi:10.1007/s12630-023-02457-8

Organ support & nutrition

Sex differences in thromboprophylaxis of the critically ill: a secondary analysis of a randomized trial

Can J AnaesthPublished 13 Jun 2023Secondary analysis of the PROTECT randomised trial

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Authors' conclusion

We found an effect modification by sex of thromboprophylaxis on VTE in critically ill patients that requires confirmation.

Study context

Population: Critically ill patients receiving thromboprophylaxis (dalteparin or UFH) in PROTECT
Participants: 1,614 vs 2,113

Comparison: Dalteparin vs UFH thromboprophylaxis, effect modification by sex
Femalen = 1,614
Malen = 2,113
Primary endpoint: Effect modification by sex of thromboprophylaxis on thrombotic (DVT, PE, VTE) and mortality outcomes

Methodological detailssex subgroup analysis, Cox proportional hazards, stratified by centre and admission diagnostic category, interaction term

Sex subgroup analysis
Cox proportional hazards
Stratified by centre and admission diagnostic category
Interaction term

Primary result

As reported in the abstract

Any VTE, dalteparin vs UFH, by sex (unadjusted)

Dalteparin vs UFH

Hazard ratio (95% CI)

Male

0.71(0.52–0.96)

Female

1.16(0.81–1.68)

Interaction P (sex × treatment): P = 0.04

Further findings

Any venous thromboembolism (VTE), adjusted for baseline characteristics

	← Lower risk ←→ Higher risk →	HR (95% CI)
MaleDalteparin vs UFH · interaction P	0.512	0.70 (0.52–0.96)
FemaleDalteparin vs UFH · interaction P	0.512	1.17 (0.81–1.68)
	0.512Hazard ratio (log scale)

Any VTE, adjusted for weight

	← Lower risk ←→ Higher risk →	HR (95% CI)
MaleDalteparin vs UFH · interaction P	0.512	0.70 (0.52–0.96)
FemaleDalteparin vs UFH · interaction P	0.512	1.20 (0.83–1.73)
	0.512Hazard ratio (log scale)

Any VTE, adjusted for baseline characteristics — Interaction P: P = 0.04
Any VTE, adjusted for weight — Interaction P: P = 0.03

Mortality

No significant effect modification by sex

DVT, proximal DVT, PE, any VTE, ICU death, hospital death (female vs male)

Similar rates in female and male participants

Original publication

Sex differences in thromboprophylaxis of the critically ill: a secondary analysis of a randomized trial. Can J Anaesth. Published 13 June 2023. doi:10.1007/s12630-023-02457-8

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