NCT01713101

Tranexamic Acid for Upper Gastrointestinal Bleeding

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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

Conditions

• Acute Upper Gastrointestinal Hemorrhage

Interventions

Type	Name	Description
DRUG	Early intravenous tranexamic acid administration	Initial history taking and physical examination --\> enrollment --\> 1g bolus over 10 minutes followed slow infusion over 8 hours.
DRUG	placebo

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2012-10-24
• Last updated: 2014-05-16

Locations

1 site across 1 country: South Korea