NCT03540368

Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Studies showed that in cases of gastrointestinal bleeding, injection tranexamic acid decreasing the risk of death and the need of surgical intervention. However, the quality of most clinical trials were not good and the results were not significant. Injection tranexamic acid does not become one of the treatment option in the international guidelines nor in national consensus, so the effectiveness and the safety of its use in the treatment of gastrointestinal bleeding remains unclear and not routinely used. In Indonesia, injection tranexamic acid in gastrointestinal bleeding is limitedly used and recorded. Therefore, a clinical trial study of injection tranexamic acid is required to assess the effectiveness and the safety in the treatment of gastrointestinal bleeding.

Detailed description

This study is a randomized double-blind controlled trial study. Interventions were given in the form of tranexamic acid injection compared to placebo in patients with acute upper and lower gastrointestinal bleeding. Tranexamic acid were administered intravenously 1 gram loading dose, followed by 3 grams maintenance dose in infusion for 24 hours. Other routine and standardized drugs for gastrointestinal bleeding will still be given. Statistical analysis will use: Chi square test or Kolmogorov-Smirnov with alternative Fisher test for categorical dependent-variable; Independent T-Test with alternative Mann-Whitney test for two-group numerical dependent-variable; and one-way ANOVA with alternative Kruskal-Wallis for more than two-groups numerical dependent-variable.

Conditions

• Gastrointestinal Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	Administering tranexamic acid loading dose 1 gram in 100 cc sodium chloride 0,9%, followed by maintenance dose 3 grams in infusion for 24 hours.
OTHER	Placebo	Administering placebo or sodium chloride 0,9% intravenously

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-03-01
• Completion: 2019-12-31
• First posted: 2018-05-30
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: Indonesia