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Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03540368
Recruitment Status : Suspended (increased number of patients death)
First Posted : May 30, 2018
Last Update Posted : August 28, 2020
Information provided by (Responsible Party):
Ari Fahrial Syam, Indonesia University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Bleeding Drug: Tranexamic acid injection Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: All patients will receive standard treatment equally
Primary Purpose: Treatment
Official Title: The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial
Actual Study Start Date : July 4, 2018
Actual Primary Completion Date : March 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

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.

Placebo Comparator: Placebo
Group with Placebo
Other: Placebo
Administering placebo or sodium chloride 0,9% intravenously

Primary Outcome Measures :
  1. Re-bleeding [ Time Frame: 30 days after randomisation ]
    Total incidence number of re-bleeding

Secondary Outcome Measures :
  1. Number of death [ Time Frame: 30 days after randomisation ]
    Total number patients who die

  2. Need for blood transfusion [ Time Frame: 30 days after randomisation ]
    Total number of patients with blood transfusion

  3. Length of stay in intensive care unit [ Time Frame: 30 days after randomisation ]
    Average time of stay each participants in intensive care unit

  4. Need for endoscopic hemostasis [ Time Frame: 30 days after randomisation ]
    Total number of patients with endoscopic hemostasis

  5. Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) [ Time Frame: 30 days after randomisation ]
    Short Form-36 Questionnaire includes one scale for each of eight measured health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. All health domain scales are scored using norm-based scores ranging 0 to 100 with higher scores indicate better health

  6. Level of anxiety [ Time Frame: 30 days after randomisation ]
    Hamilton Anxiety Rating Scale; Each item is scored of 0 (not present) to 4 (severe), with total score range of 0-56, where <14 indicates no anxiety, 14-20 mild anxiety, 21-27 moderate anxiety, 28-41 severe anxiety and 42-56 very severe anxiety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03540368

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Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
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Principal Investigator: Ari F Syam, Dr, MD Gastroenterology Division, Internal Medicine Department RSCM/UI
  Study Documents (Full-Text)

Documents provided by Ari Fahrial Syam, Indonesia University:
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Responsible Party: Ari Fahrial Syam, Medical Doctor, Gastroenterology Hepatology Consultant, Indonesia University Identifier: NCT03540368    
Other Study ID Numbers: 18-04-0393
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ari Fahrial Syam, Indonesia University:
Gastrointestinal bleeding
Tranexamic acid
Clinical trial
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action