Tranexamic Acid in Gastrointestinal Bleeding
Based on the most recent high-quality evidence, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of clinical trials. 1
Current Evidence on Efficacy
- The HALT-IT trial, a large international randomized controlled trial with 12,009 patients, demonstrated that tranexamic acid did not reduce death from gastrointestinal bleeding compared to placebo (4% vs 4%, risk ratio 0.99,95% CI 0.82-1.18) 1
- While earlier meta-analyses of small trials suggested potential benefit with a 40% risk reduction in mortality, this treatment benefit disappeared when analysis was limited to trials with low risk of bias 2
- Historical studies on tranexamic acid in upper GI bleeding were conducted before the routine use of high-dose acid suppression and endoscopic therapy, making their extrapolation to modern care uncertain 2
Safety Concerns
- The HALT-IT trial found that venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were significantly higher in the tranexamic acid group compared to placebo (0.8% vs 0.4%, RR 1.85,95% CI 1.15-2.98) 1
- Seizures occurred more frequently with tranexamic acid than with placebo (0.6% vs 0.4%, RR 1.73,95% CI 1.03-2.93) 3
- Arterial thromboembolic events were similar between tranexamic acid and placebo groups (0.7% vs 0.8%, RR 0.92,95% CI 0.60-1.39) 1
Recommendations from Guidelines
- The British Society of Gastroenterology (2019) explicitly recommends that the use of tranexamic acid in acute lower gastrointestinal bleeding should be confined to clinical trials 2
- This recommendation was made pending the results of the HALT-IT trial, which has since been published with negative findings 2, 1
- Despite its proven efficacy in trauma-related bleeding and incorporation into massive transfusion protocols, the evidence does not support tranexamic acid use in GI bleeding 2, 4
Contrasting Evidence
- Some smaller meta-analyses prior to HALT-IT suggested potential benefits:
- A 2008 systematic review found tranexamic acid may reduce all-cause mortality (RR: 0.61,95% CI: 0.42-0.89) but noted significant limitations in the included trials 5
- A 2021 meta-analysis of 13 RCTs (n=2271) suggested tranexamic acid reduced continued bleeding (RR=0.60), urgent endoscopic intervention (RR=0.35), and mortality (RR=0.60) compared to placebo 6
- However, these findings are overshadowed by the much larger and more robust HALT-IT trial 1, 3
Clinical Implications
- Despite being inexpensive, tranexamic acid is not cost-effective in adults with acute gastrointestinal bleeding and may result in slightly poorer health outcomes 3
- The negative findings from HALT-IT caution against a uniform approach to managing patients with major hemorrhage and highlight the need for targeted treatments based on specific pathophysiological processes 3
- Hospitals should have a GI bleeding lead and agreed pathways for management of acute GI bleeding, but these should not routinely include tranexamic acid 2
Conclusion
- The most robust evidence from the HALT-IT trial shows no mortality benefit from tranexamic acid in GI bleeding with potential increased risk of venous thromboembolism 1, 3
- While tranexamic acid has proven benefits in trauma and surgical bleeding, these benefits do not extend to gastrointestinal bleeding 4, 1