From the Guidelines
Tranexamic acid (TXA) should not be used to stop gastrointestinal (GI) bleeding.
Rationale
- The use of tranexamic acid in acute GI bleeding has been evaluated in several studies, but the evidence is not strong enough to support its use in clinical practice 1.
- A large randomized placebo-controlled trial including 12,009 patients with acute upper gastrointestinal bleeding found no beneficial effect of tranexamic acid on mortality, and an increased risk of venous thromboembolic events 1.
- The European Association for the Study of the Liver (EASL) clinical practice guidelines recommend against the use of tranexamic acid in patients with cirrhosis and active variceal bleeding, as well as in patients with cirrhosis undergoing invasive procedures 1.
- The guidelines suggest that the use of tranexamic acid may be considered on a case-by-case basis in patients with cirrhosis and active bleeding related to portal hypertension, but not to varices, or in patients with cirrhosis who are actively bleeding from a non-portal hypertensive cause 1.
- However, the overall consensus is that tranexamic acid should not be used as a first-line treatment for GI bleeding, and its use should be carefully considered in specific clinical scenarios.
- Key points to consider when evaluating the use of tranexamic acid in GI bleeding include:
- The underlying cause of the bleeding
- The presence of cirrhosis or other underlying liver disease
- The risk of thromboembolic events
- The availability of other treatment options, such as endoscopic therapy or portal hypertension-lowering drugs.
From the FDA Drug Label
Tranexamic acid (TXA) is not indicated for gastrointestinal (GI) bleeding. The drug labels for tranexamic acid (2, 2) only mention its use in patients with hemophilia for short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. There is no direct information that supports the use of tranexamic acid for GI bleeding.
- The indications and usage section of the drug labels (2, 2) does not mention GI bleeding as an approved use.
- The adverse reactions section of the drug label (2) mentions gastrointestinal symptoms such as nausea, vomiting, and diarrhea as possible side effects, but this does not imply that the drug is used to treat GI bleeding.
- The overdosage section of the drug label (2) mentions gastrointestinal symptoms as possible symptoms of overdosage, but again, this does not support the use of tranexamic acid for GI bleeding.
From the Research
Effectiveness of Tranexamic Acid in GI Bleeding
- Tranexamic acid (TXA) has been studied for its effectiveness in stopping gastrointestinal (GI) bleeding, with evidence suggesting it can reduce rebleeding and mortality in patients with upper GI bleeding 3, 4, 5.
- A meta-analysis of randomized controlled trials found that TXA significantly reduced the rates of continued bleeding, urgent endoscopic intervention, and mortality compared to placebo 5.
- Another study found that TXA with acid suppression significantly reduced the risk of rebleeding, units of blood transfused, and the need for salvage therapy compared to acid suppression alone 4.
Safety and Adverse Effects
- The evidence suggests that TXA does not increase the risk of thromboembolic adverse effects in patients with upper GI bleeding 3, 6.
- However, the reporting of adverse events in some studies was unclear, highlighting the need for further research to fully understand the safety profile of TXA in GI bleeding 6.
Clinical Applications
- The HALT-IT trial, a large international randomized controlled trial, aims to provide reliable evidence on the effects of TXA in acute upper and lower GI bleeding 7.
- The trial will compare the effects of TXA with placebo on outcomes such as death due to bleeding, rebleeding, and thromboembolic events, and will inform clinical practice guidelines for the use of TXA in GI bleeding 7.
Limitations and Future Research
- While the current evidence suggests that TXA can be effective in reducing GI bleeding, further research is needed to fully understand its effects, particularly in lower GI bleeding 5.
- Additional studies should investigate the optimal dose and route of TXA administration, as well as its use in combination with other treatments, such as acid suppression 4.