CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Tranexamic acid injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03540368
NCT03540368N/ACompleted

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

Indonesia University·interventional·Posted May 30, 2018·Updated Mar 27, 2026

In Brief

A clinical study evaluating Tranexamic acid injection and Placebo for Gastrointestinal Bleeding. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 30, 2018
Enrollment StartJul 1, 2018
Primary CompletionMar 1, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.1 years ago

Interventions

Tranexamic acid injectiondrug

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.

Placeboother

Administering placebo or sodium chloride 0,9% intravenously