From the Guidelines
Tranexamic acid (TXA) may not be effective in stopping gastrointestinal (GI) bleeding, particularly in cases of variceal bleeding.
Evidence Summary
- A large randomized placebo-controlled trial published in 2022 1 found no beneficial effect of intravenous tranexamic acid in patients with acute upper gastrointestinal bleeding, including those with suspected variceal bleeding and liver disease comorbidity.
- The same study found an almost 2-fold increase in the incidence of venous thromboembolic events in the tranexamic acid group compared to the placebo group, particularly in patients with comorbid liver disease/suspected variceal bleeding.
- The British Society of Gastroenterology guidelines published in 2019 1 suggest that the use of tranexamic acid in acute lower gastrointestinal bleeding be confined to clinical trials, pending the results of the HALT-IT trial.
- The European Society of Intensive Care Medicine guidelines published in 2021 1 suggest not using high-dose IV TXA in critically ill patients with gastrointestinal bleeding, but make no recommendation regarding the use of low-dose IV TXA or enteral TXA.
Key Points
- TXA may not be effective in variceal bleeding: The evidence suggests that tranexamic acid may not be effective in stopping variceal bleeding, and may even increase the risk of thromboembolic events.
- Limited role in GI bleeding: The use of tranexamic acid in gastrointestinal bleeding is not well established, and its effectiveness is uncertain.
- Risk of thromboembolic events: The use of tranexamic acid may increase the risk of thromboembolic events, particularly in patients with comorbid liver disease/suspected variceal bleeding.
From the FDA Drug Label
Tranexamic Acid (TXA) and Gastrointestinal (GI) Bleeding
Overview of TXA
Tranexamic acid (TXA) is an antifibrinolytic agent, which means it works by preventing the breakdown of blood clots [ 2 ].
GI Bleeding and TXA
There is no direct information in the provided FDA Drug Label that suggests tranexamic acid (TXA) can stop gastrointestinal (GI) bleeding. The label primarily discusses symptoms of overdosage, which include gastrointestinal symptoms such as nausea, vomiting, and diarrhea, but does not indicate the use of TXA for treating GI bleeding [ 2 ].
Key Points
- TXA is an antifibrinolytic agent.
- The provided FDA Drug Label does not support the use of TXA for stopping GI bleeding.
- Symptoms of TXA overdosage may include gastrointestinal issues, but this does not imply efficacy in treating GI bleeding.
From the Research
Effectiveness of Tranexamic Acid in GI Bleeding
- The effectiveness of tranexamic acid (TXA) in stopping gastrointestinal (GI) bleeding is a topic of ongoing research, with studies yielding mixed results 3, 4, 5, 6.
- A 2024 study published in the World Journal of Surgery found that intravenous TXA had no significant effect on blood requirement in patients with lower GI bleeding, with no difference in the consumption of packed red blood cells (PRBC) units among patients in the placebo and TXA groups 3.
- In contrast, a 2021 systematic review and meta-analysis published in The American Journal of Emergency Medicine found that TXA significantly reduced the rates of continued bleeding, urgent endoscopic intervention, and mortality in patients with upper GI bleeding, suggesting that early administration of TXA may be beneficial in treating upper GI bleeding 4.
- A 2022 population-based cohort study published in the Journal of Clinical Medicine found that early TXA treatment was associated with a reduced risk of mortality in patients with GI bleeding, without an increase in thromboembolic events 5.
- A 2020 systematic review and meta-analysis published in Alimentary Pharmacology & Therapeutics found that TXA was superior to placebo in reducing mortality in patients with upper GI bleeding, with moderate-quality evidence supporting its use 6.
GI Bleeding Subtypes and TXA Efficacy
- The efficacy of TXA in GI bleeding may vary depending on the subtype of bleeding, with some studies suggesting that TXA is more effective in upper GI bleeding than in lower GI bleeding 3, 4.
- Further research is needed to clarify the effects of TXA on lower GI bleeding, as well as to determine the optimal timing and dosage of TXA administration in patients with GI bleeding 4, 5.
Clinical Implications
- The available evidence suggests that TXA may be a useful adjunctive treatment in patients with upper GI bleeding, particularly when administered early 4, 6.
- However, the use of TXA in lower GI bleeding remains uncertain, and further studies are needed to determine its efficacy and safety in this setting 3, 4.