POISE-3 (original research)
Trial question
What is the role of tranexamic acid in patients undergoing noncardiac surgery?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 9535
9535 patients (4185 female, 5350 male).
Inclusion criteria: adult patients undergoing noncardiac surgery.
Key exclusion criteria: patients undergoing cardiac surgery or cranial neurosurgery; use of systemic tranexamic acid during surgery; CrCl < 30 mL/min; receipt of long-term dialysis.
Interventions
N=4757 tranexamic acid (prophylactic 1 g intravenous bolus of tranexamic acid given at the start and end of surgery).
N=4778 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
9.1%
11.7%
11.7 %
8.8 %
5.8 %
2.9 %
0.0 %
Tranexamic
acid
Placebo
Significant
decrease ▼
NNT = 38
Significant decrease in composite outcome of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days (9.1% vs. 11.7%; HR 0.76, 95% CI 0.67 to 0.87).
Secondary outcomes
No significant difference in life-threatening bleeding at 30 days (1.6% vs. 1.7%; HR 0.99, 99% CI 0.73 to 1.36).
Significant decrease in major bleeding at 30 days (7.6% vs. 10.4%; HR 0.72, 95% CI 0.63 to 0.83).
No significant difference in critical organ bleeding at 30 days (0.3% vs. 0.4%; HR 0.57, 95% CI 0.28 to 1.16).
Safety outcomes
No significant difference in cardiovascular outcome event at 30 days.
Conclusion
In adult patients undergoing noncardiac surgery, 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
P J Devereaux, Maura Marcucci, Thomas W Painter et al. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997.
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