POISE-3 (subgroup analysis)
Trial question
What is the effect of prophylactic tranexamic acid for the prevention of major bleeding in patients undergoing general surgery procedures?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 3260
3260 patients (1520 female, 1740 male).
Inclusion criteria: patients undergoing general surgery procedures.
Key exclusion criteria: cardiac surgery; intracranial neurosurgery; planned use of systemic tranexamic acid during surgery; low-risk surgical procedure; hypersensitivity or allergy to tranexamic acid; seizure disorder; recent stroke, MI, acute arterial thrombosis, or VTE.
Interventions
N=1635 tranexamic acid (prophylactic 1 g intravenous bolus of tranexamic acid given at the start and end of surgery).
N=1625 placebo (1 g 0.9% normal saline at the start and end of surgery).
Primary outcome
Composite outcome of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days
8%
10.5%
10.5 %
7.9 %
5.3 %
2.6 %
0.0 %
Tranexamic
acid
Placebo
Significant
decrease ▼
NNT = 40
Significant decrease in composite outcome of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days (8% vs. 10.5%; HR 0.74, 95% CI 0.59 to 0.93).
Secondary outcomes
No significant difference in life-threatening bleeding at 30 days (1.5% vs. 1.5%; HR 0.99, 99% CI 0.57 to 1.73).
Significant decrease in major bleeding at 30 days (6.7% vs. 9.4%; HR 0.71, 95% CI 0.55 to 0.9).
No significant difference in critical organ bleeding at 30 days (0.2% vs. 0.1%; HR 1.98, 95% CI 0.36 to 10.8).
Safety outcomes
No significant difference in cardiovascular and thromboembolic events at 30 days.
Conclusion
In patients undergoing general surgery procedures, tranexamic acid was superior to placebo with respect to the composite outcome of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days.
Reference
Lily J Park, Maura Marcucci, Sandra N Ofori et al. Safety and Efficacy of Tranexamic Acid in General Surgery. JAMA Surg. 2025 Jan 15. Online ahead of print.
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