Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

Study Overview
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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.

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.

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

Conditions
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Gastrointestinal Bleeding

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid injection<br>Group with tranexamic acid injection | Drug: Tranexamic acid injection<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Group with Placebo | Other: Placebo<br>* Administering placebo or sodium chloride 0,9% intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-bleeding | Total incidence number of re-bleeding | 30 days after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of death | Total number patients who die | 30 days after randomisation | 
| Need for blood transfusion | Total number of patients with blood transfusion | 30 days after randomisation | 
| Length of stay in intensive care unit | Average time of stay each participants in intensive care unit | 30 days after randomisation | 
| Need for endoscopic hemostasis | Total number of patients with endoscopic hemostasis | 30 days after randomisation | 
| Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) | 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 | 30 days after randomisation | 
| Level of anxiety | 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 | 30 days after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal bleeding, Tranexamic acid, Clinical trial