Tranexamic Acid for Upper Gastrointestinal Bleeding (TAUGIB)

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

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

Study Overview

• Status: Unknown
• Conditions: Acute Upper Gastrointestinal Hemorrhage
• Intervention / Treatment: Drug: placebo; Drug: Early intravenous tranexamic acid administration

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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

• Study Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kyuseok Kim, MD; Phone Number: +82-31-787-7572; Email: dremkks@snubh.org
• Study Contact Backup: Name: Joonghee Kim, MD; Phone Number: +82-10-9489-3696; Email: joonghee@me.com

Study Locations

• Korea, Republic of
  • Kyeongi-do
    • Seongnam-si, Kyeongi-do, Korea, Republic of
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Kyuseok Kim, MD; Phone Number: +82-31-787-7572; Email: dremkks@snubh.org
      • Contact: Joonghee Kim, MD; Phone Number: +82-10-9489-3696; Email: joonghee@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early intravenous tranexamic acid administration; Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours	Drug: Early intravenous tranexamic acid administration; Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.; Other Names: tranexamic acid administration; transamine administration; antifibrinolytics administration
Placebo Comparator: Placebo group; Normal saline (placebo) administration instead of tranexamic acid solution	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients requiring early endoscopic treatment	Within 24 hours of emergency department visit

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect modification by hyperfibrinolysis and other coagulation related factors	Separate analysis looking into the interaction between coagulation function and tranexamic acid effect	Variable (within 24-hour and 1-month of emergency department visit)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Kyuseok Kim, MD, Professor, department of emergency medicine; Principal Investigator: Sang Hyub Lee, MD, Professor, department of internal medicine (gastroenterology); Principal Investigator: Cheol Min Shin, MD, Professor, department of internal medicine (gastroenterology)

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: May 14, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Tranexamic acid; Peptic Ulcer Hemorrhage; Gastrointestinal Hemorrhage; Melena; Hematemesis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Fibrin Modulating Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Anti-Anxiety Agents; Hemostatics; Coagulants; Monoamine Oxidase Inhibitors; Tranexamic Acid; Tranylcypromine; Antifibrinolytic Agents
• Other Study ID Numbers: B-1207-163-002