search
Back to results

Tranexamic Acid for Upper Gastrointestinal Bleeding (TAUGIB)

Primary Purpose

Acute Upper Gastrointestinal Hemorrhage

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Early intravenous tranexamic acid administration
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Gastrointestinal Hemorrhage focused on measuring Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena, Tranexamic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Early intravenous tranexamic acid administration

Placebo group

Arm Description

Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours

Normal saline (placebo) administration instead of tranexamic acid solution

Outcomes

Primary Outcome Measures

Proportion of patients requiring early endoscopic treatment

Secondary Outcome Measures

Endoscopic signs of bleeding
Length of stay
Need for urgent endoscopy
Endoscopic procedure time/difficulty
Need for transfusion
Need for surgery/angiographic intervention
rate of recurrent bleeding
death of any cause
thromboembolic complications

Full Information

First Posted
October 18, 2012
Last Updated
May 14, 2014
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01713101
Brief Title
Tranexamic Acid for Upper Gastrointestinal Bleeding
Acronym
TAUGIB
Official Title
Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Gastrointestinal Hemorrhage
Keywords
Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena, Tranexamic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early intravenous tranexamic acid administration
Arm Type
Experimental
Arm Description
Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Normal saline (placebo) administration instead of tranexamic acid solution
Intervention Type
Drug
Intervention Name(s)
Early intravenous tranexamic acid administration
Other Intervention Name(s)
tranexamic acid administration, transamine administration, antifibrinolytics administration
Intervention Description
Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Proportion of patients requiring early endoscopic treatment
Time Frame
Within 24 hours of emergency department visit
Secondary Outcome Measure Information:
Title
Endoscopic signs of bleeding
Time Frame
Within 24 hours of emergency department visit
Title
Length of stay
Time Frame
Within one-month of emergency department visit
Title
Need for urgent endoscopy
Time Frame
Within 24 hours of emergency department visit
Title
Endoscopic procedure time/difficulty
Time Frame
Within 24 hours of emergency department visit
Title
Need for transfusion
Time Frame
Within one-month of emergency department visit
Title
Need for surgery/angiographic intervention
Time Frame
Within one-month of emergency department visit
Title
rate of recurrent bleeding
Time Frame
Within one-month of emergency department visit
Title
death of any cause
Time Frame
Within one-month of emergency department visit
Title
thromboembolic complications
Time Frame
Within one-month of emergency department visit
Other Pre-specified Outcome Measures:
Title
Effect modification by hyperfibrinolysis and other coagulation related factors
Description
Separate analysis looking into the interaction between coagulation function and tranexamic acid effect
Time Frame
Variable (within 24-hour and 1-month of emergency department visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chief complaint of hematemesis, melena or hematochezia and objective signs of upper gastrointestinal bleeding Exclusion Criteria: Pregnant woman, age less than 18 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 Previous history of variceal bleeding Cases where informed consent is unobtainable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyuseok Kim, MD
Phone
+82-31-787-7572
Email
dremkks@snubh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joonghee Kim, MD
Phone
+82-10-9489-3696
Email
joonghee@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Organizational Affiliation
Professor, department of emergency medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD
Organizational Affiliation
Professor, department of internal medicine (gastroenterology)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheol Min Shin, MD
Organizational Affiliation
Professor, department of internal medicine (gastroenterology)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Kyeongi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Phone
+82-31-787-7572
Email
dremkks@snubh.org
First Name & Middle Initial & Last Name & Degree
Joonghee Kim, MD
Phone
+82-10-9489-3696
Email
joonghee@me.com

12. IPD Sharing Statement

Learn more about this trial

Tranexamic Acid for Upper Gastrointestinal Bleeding

We'll reach out to this number within 24 hrs