6/29/23, 1:41 AM POISE-3 Pathway Feedback Search Clinical Topics Home Studies POISE 3 POISE 3 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 N = 9535 56.0% male 9535 patients (4183 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 (1 g intravenous bolus at the start and end of surgery) N=4778 placebo (1 g 0.9% normal saline at the start and end of the surgery) Primary outcome Composite outcome of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days 11.7 % 11.7 9.1 8.8 % 5.8 % Significant decrease 2.9 % NNT = 38 https://web.pathway.md/studies/rec3h33rCJR4eZQeu 1/2 6/29/23, 1:41 AM POISE-3 Pathway 0.0 % Tranexamic acid Placebo 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 (1.6% vs. 1.7%; HR 0.99, 99% CI 0.73 to 1.36) Borderline significant decrease in major bleeding (7.6% vs. 10.4%; HR 0.72, 95% CI 0.63 to 0.83) No significant difference in bleeding into a critical organ (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. Open reference URL https://web.pathway.md/studies/rec3h33rCJR4eZQeu 2/2