Tranexamic Acid for Upper Gastrointestinal Bleeding — TAUGIB  

Acute Upper Gastrointestinal Hemorrhage Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Hemorrhage
• Gastrointestinal Hemorrhage
• Hemorrhage

• NCT number: NCT01713101
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Kyuseok Kim, MD
• Phone: +82-31-787-7572
• Email: dremkks@snubh.org
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2012
• Completion date: August 2015