Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2020-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

All patients will receive standard treatment equally

Study Groups

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Tranexamic acid injection

Group with tranexamic acid injection

Group Type EXPERIMENTAL

Tranexamic acid injection

Intervention Type DRUG

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

Group with Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administering placebo or sodium chloride 0,9% intravenously

Interventions

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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.

Intervention Type DRUG

Placebo

Administering placebo or sodium chloride 0,9% intravenously

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No