Tranexamic Acid for Upper Gastrointestinal Bleeding

Seoul National University Hospital414 enrolled

Overview

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

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

414

Conditions

Acute Upper Gastrointestinal Hemorrhage

Interventions

Early intravenous tranexamic acid administrationDRUG

Initial history taking and physical examination --\> enrollment --\> 1g bolus over 10 minutes followed slow infusion over 8 hours.

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyeongi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients requiring early endoscopic treatment

Time frame: Within 24 hours of emergency department visit