Tranexamic Acid for Upper Gastrointestinal Bleeding

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Antifibrinolytic Agents; Tranexamic Acid; Tranylcypromine

Criteria

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