From the Guidelines
Tranexamic acid (TXA) should not be used to stop a gastrointestinal (GI) bleed, as the current evidence does not support its effectiveness in this context.
Mechanism of Action and Clinical Evidence
- TXA is an antifibrinolytic agent that works by inhibiting the breakdown of fibrin clots, thereby promoting hemostasis 1.
- A large randomized placebo-controlled trial including 12,009 patients with acute upper gastrointestinal bleeding found no beneficial effect of TXA in stopping GI bleeds, and an increased risk of venous thromboembolic events was observed in the TXA group 1.
- The European Society of Intensive Care Medicine guidelines state that there is high certainty of harms with the use of high-dose IV TXA and no clear benefit with its general use in gastrointestinal hemorrhage 1.
Specific Considerations
- In patients with cirrhosis and active variceal bleeding, TXA should not be used, as recommended by the EASL clinical practice guidelines 1.
- The use of TXA in acute lower gastrointestinal bleeding is currently not recommended outside of clinical trials, pending the results of further studies 1.
- More research is needed to evaluate the role of enteral and low-dose intravenous TXA, and the potential role of TXA as rescue therapy in refractory hemorrhage 1.
From the FDA Drug Label
Tranexamic Acid (TXA) is not indicated to stop a gastrointestinal (GI) bleed.
- The drug labels for tranexamic acid (2, 2, 2) do not provide information on its use for treating gastrointestinal bleeds.
- The indications for tranexamic acid include short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction in patients with hemophilia (2, 2).
- The drug labels list various warnings, precautions, and adverse reactions, but do not mention the treatment of gastrointestinal bleeds (2, 2).
- The absence of information on the use of tranexamic acid for gastrointestinal bleeds in the drug labels does not provide sufficient evidence to support its use for this indication.
From the Research
Effectiveness of Tranexamic Acid in Gastrointestinal Bleeding
- Tranexamic acid (TXA) has been studied as a potential treatment for gastrointestinal (GI) bleeding, with evidence suggesting it may be effective in reducing bleeding and mortality in certain cases 3, 4, 5.
- A systematic review and meta-analysis of randomized controlled trials found that TXA significantly reduced the rates of continued bleeding, urgent endoscopic intervention, and mortality compared to placebo in patients with upper GI bleeding 3.
- Another study found that low-dose IV/enteral TXA reduced the risk of rebleeding and need for surgery, but did not reduce mortality 6.
- The HALT-IT trial, a large international randomized controlled trial, aimed to provide reliable evidence on the effects of TXA in acute upper and lower GI bleeding, but the results are not yet fully published 7.
Safety and Adverse Events
- The use of high-dose IV TXA has been associated with an increased risk of deep venous thrombosis, pulmonary embolism, and seizure 6.
- Low-dose IV/enteral TXA may be safer, but more evidence is needed to demonstrate its safety 6.
- The risk of thromboembolic events with TXA is unclear, with some studies suggesting an increased risk and others finding no significant difference 4, 5.
Clinical Applications
- TXA may be considered as an adjunctive treatment for upper GI bleeding, particularly in cases where endoscopic treatment is not immediately available 3, 5.
- The use of TXA in lower GI bleeding is less well-studied and requires further clarification 3, 6.
- The optimal dosing strategy for TXA in GI bleeding is unclear, with different studies using varying doses and administration routes 6, 7.