Tranexamic Acid for Upper Gastrointestinal Bleeding

Study Overview
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Brief Summary
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This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.

Detailed Description
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Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including Gut suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.

Official Title
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Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy

Conditions
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Acute Upper Gastrointestinal Hemorrhage

Intervention / Treatment
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* Drug: Early intravenous tranexamic acid administration
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chief complaint of hematemesis, melena or hematochezia and objective signs of upper gastrointestinal bleeding Exclusion Criteria: Pregnant woman, age less than 18 Patients whose use of the study drug is contraindicated Increased thromboembolic risk History of thromboembolic disease Alleged inherited thrombophilic disorders Malignancy (except those cured and has not recurred more than two years) Nephrotic syndrome Estrogen use Pregnancy HIT, APA High-risk for cardioembolism Underlying structural heart disease where anticoagulation is indicated Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter) Possibilities of ongoing DIC Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature > 38 degree) Any malignancy except those cured and has not recurred more than two years Patients with history or presence of subarachnoid hemorrhage Acquired color vision impairment, visual loss and retinal venous and arterial occlusions Past history of seizure or organic brain lesion that predispose to seizure disorder Previous history of variceal bleeding Cases where informed consent is unobtainable

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early intravenous tranexamic acid administration<br>Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours | Drug: Early intravenous tranexamic acid administration<br>* Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.<br>* Other names: antifibrinolytics administration;|
| Placebo Comparator: Placebo group<br>Normal saline (placebo) administration instead of tranexamic acid solution | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients requiring early endoscopic treatment |  | Within 24 hours of emergency department visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic signs of bleeding |  | Within 24 hours of emergency department visit | 
| Length of stay |  | Within one-month of emergency department visit | 
| Need for urgent endoscopy |  | Within 24 hours of emergency department visit | 
| Endoscopic procedure time/difficulty |  | Within 24 hours of emergency department visit | 
| Need for transfusion |  | Within one-month of emergency department visit | 
| Need for surgery/angiographic intervention |  | Within one-month of emergency department visit | 
| rate of recurrent bleeding |  | Within one-month of emergency department visit | 
| death of any cause |  | Within one-month of emergency department visit | 
| thromboembolic complications |  | Within one-month of emergency department visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena, Tranexamic acid