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Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

NCT03540368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-27

Study results available
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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.

Conditions

  • Gastrointestinal Bleeding

Interventions

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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Ari F Syam, Dr, MD · Gastroenterology Division, Internal Medicine Department RSCM/UI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-03-01
Completion
2019-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540368 on ClinicalTrials.gov