Safety and Efficacy of Tranexamic Acid in General Surgery.
Summary
In 3,260 general surgery patients within POISE-3, prophylactic TXA reduced the composite bleeding outcome (HR 0.74; 95% CI, 0.59-0.93; P=0.01) without increasing the composite cardiovascular safety outcome (HR 0.95; 95% CI, 0.78-1.16). Benefits were consistent across general surgery subtypes, including hepatopancreaticobiliary and colorectal procedures.
Key Findings
- TXA reduced life-threatening/major/critical organ bleeding composite vs placebo (HR 0.74; 95% CI 0.59-0.93).
- No increase in cardiovascular safety composite (myocardial injury after noncardiac surgery, nonhemorrhagic stroke, arterial thrombosis, symptomatic proximal VTE) with TXA (HR 0.95; 95% CI 0.78-1.16).
- Benefit observed across general surgery subtypes, notably hepatopancreaticobiliary (HR 0.55; 95% CI 0.34-0.91) and colorectal (HR 0.67; 95% CI 0.45-0.98) surgery.
Clinical Implications
Anesthesiologists can consider routine prophylactic TXA in eligible general surgery patients to reduce major bleeding without increasing vascular events, with particular benefit in hepatopancreaticobiliary and colorectal procedures.
Why It Matters
Provides high-quality randomized evidence supporting TXA use in general surgery with reassuring safety, informing perioperative blood management protocols.
Limitations
- Subgroup analysis inherits limitations of secondary analyses and may be underpowered for rare harms
- Applicability limited to patients similar to POISE-3 eligibility (≥45 years, elevated cardiovascular risk)
Future Directions
Implementation studies to optimize TXA dosing/timing in specific general surgery pathways and evaluate real-world effectiveness and rare adverse events.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- II - High-quality randomized trial subgroup analysis within a large multicenter RCT
- Study Design
- OTHER