Tranexamic Acid for Upper Gastrointestinal Bleeding

Phase 3

• Conditions: Acute Upper Gastrointestinal Hemorrhage
• Interventions: Drug: placebo; Drug: Early intravenous tranexamic acid administration

• Registration Number: NCT01713101
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-16
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

1. Chief complaint of hematemesis, melena or hematochezia
2. and objective signs of upper gastrointestinal bleeding

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Exclusion Criteria

1. Pregnant woman, age less than 18

2. 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

3. Previous history of variceal bleeding

4. Cases where informed consent is unobtainable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo	Normal saline (placebo) administration instead of tranexamic acid solution
Early intravenous tranexamic acid administration	Early intravenous tranexamic acid administration	Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours

Primary Outcome Measures

Name	Time	Method
Proportion of patients requiring early endoscopic treatment	Within 24 hours of emergency department visit

Secondary Outcome Measures

Name	Time	Method
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
Need for transfusion	Within one-month of emergency department visit
thromboembolic complications	Within one-month of emergency department visit
Need for surgery/angiographic intervention	Within one-month of emergency department visit
Endoscopic procedure time/difficulty	Within 24 hours 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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Kyeongi-do, Korea, Republic of