N/A
N=42
Tranexamic Acid for The Treatment of Gastrointestinal Bleeding
Gastrointestinal Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03540368 ↗Enrolled (actual)
42
Serious AEs
4.8%
Results posted
Mar 2026
Primary outcome: Primary: Re-bleeding — 6; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tranexamic acid injection (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indonesia University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Re-bleeding |
6; 7 | — |
| SECONDARY All Cause Mortality |
4; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults
- Patients with acute lower and upper gastrointestinal bleeding (assessed clinically)
- Patients agreed to participate in the study and signed the informed consent
Exclusion Criteria
- Allergy with tranexamic acid
- Patients considered by the clinician can not be randomized to participate in the study
- Patients with chronic kidney disease stage III - V
Data sourced from ClinicalTrials.gov (NCT03540368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.