Hemodynamics, fluids & transfusion

Safety and Efficacy of Tranexamic Acid in General Surgery

JAMA SurgPublished Secondary analysis of the POISE-3 randomised trial

Primary result · Primary efficacy outcome (composite bleeding), general surgeryResult — go to the resultHazard ratio 0.74 95% CI 0.59–0.93

Authors' conclusion

In this study, TXA significantly reduced the risk of perioperative bleeding without increasing cardiovascular risk in patients undergoing general surgery procedures.

Study context

Population
Patients ≥45 years undergoing general surgery (noncardiac) with increased cardiovascular risk, expected at least overnight admissionof 9535 POISE-3 participants
Participants
3,260 patients
Comparison
Tranexamic acid (TXA) vs placebo in general surgery
Primary endpoint
Composite of:
  • Life-threatening bleeding
  • Major bleeding
  • Bleeding into a critical organ
Methodological detailssubgroup analysis, blinded, international, multicentre, Enrolled June 2018 through July 2021
  • Subgroup analysis
  • Blinded
  • International
  • Multicentre
  • Enrolled June 2018 through July 2021

Primary result

As reported in the abstract

Primary efficacy outcome (composite bleeding), general surgery

Hazard ratio

0.74

95% CI 0.59–0.93

P = 0.01

By group

TXA vs Placebo
HR 0.74 (95% CI 0.59–0.93); P = 0.01

Further findings

OutcomeHR (95% CI)
Composite bleeding, hepatopancreaticobiliary surgery (subgroup)n = 3320.55 (0.34–0.91)
Composite bleeding, colorectal surgery (subgroup)n = 9400.67 (0.45–0.98)
  • Composite bleeding, colorectal surgery (subgroup): no significant interaction across subtypes of general surgery (P for interaction = .68)

Safety

OutcomeTXAPlaceboHR (95% CI)P value
Primary safety outcome (MINS, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal VTE), general surgery · 30 days11.9%12.5%0.95 (0.78–1.16)P = 0.63
  • Primary safety outcome (MINS, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal VTE), general surgery: no significant interaction by type of surgery (P for interaction = .37)

Original publication

Safety and Efficacy of Tranexamic Acid in General Surgery. JAMA Surg. Published 1 March 2025. doi:10.1001/jamasurg.2024.6048

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