Clinical Trial: Tranexamic Acid for Upper Gastrointestinal Bleeding

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary: 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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: Proportion of patients requiring early endoscopic treatment [ Time Frame: Within 24 hours of emergency department visit ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Endoscopic signs of bleeding [ Time Frame: Within 24 hours of emergency department visit ]
  • Length of stay [ Time Frame: Within one-month of emergency department visit ]
  • Need for urgent endoscopy [ Time Frame: Within 24 hours of emergency department visit ]
  • Endoscopic procedure time/difficulty [ Time Frame: Within 24 hours of emergency department visit ]
  • Need for transfusion [ Time Frame: Within one-month of emergency department visit ]
  • Need for surgery/angiographic intervention [ Time Frame: Within one-month of emergency department visit ]
  • rate of recurrent bleeding [ Time Frame: Within one-month of emergency department visit ]
  • death of any cause [ Time Frame: Within one-month of emergency department visit ]
  • thromboembolic complications [ Time Frame: Within one-month of emergency department visit ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: October 18, 2012
Date Started: October 2012
Date Completion: August 2015
Last Updated: May 14, 2014
Last Verified: May 2014