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

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 Overview

• Status: Completed
• Conditions: Gastrointestinal Bleeding
• Intervention / Treatment: Drug: Tranexamic acid injection; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo National Central General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid injection; Group with tranexamic acid injection	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 Names: TXA
Placebo Comparator: Placebo; Group with Placebo	Other: Placebo; Administering placebo or sodium chloride 0,9% intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-bleeding	The number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation	28 days after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Mortality	Total number patients who die	30 days after randomisation

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Ari F Syam, Dr, MD, Gastroenterology Division, Internal Medicine Department RSCM/UI

Publications and helpful links

General Publications

• Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Clinical trial; Tranexamic acid; Gastrointestinal bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 18-04-0393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No