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Tranexamic Acid for Upper Gastrointestinal Bleeding (TAUGIB)

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ClinicalTrials.gov Identifier: NCT01713101
Recruitment Status : Unknown
Verified May 2014 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 24, 2012
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Acute Upper Gastrointestinal Hemorrhage Drug: Early intravenous tranexamic acid administration Drug: placebo Phase 3

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy
Study Start Date : October 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. Endoscopic signs of bleeding [ Time Frame: Within 24 hours of emergency department visit ]
  2. Length of stay [ Time Frame: Within one-month of emergency department visit ]
  3. Need for urgent endoscopy [ Time Frame: Within 24 hours of emergency department visit ]
  4. Endoscopic procedure time/difficulty [ Time Frame: Within 24 hours of emergency department visit ]
  5. Need for transfusion [ Time Frame: Within one-month of emergency department visit ]
  6. Need for surgery/angiographic intervention [ Time Frame: Within one-month of emergency department visit ]
  7. rate of recurrent bleeding [ Time Frame: Within one-month of emergency department visit ]
  8. death of any cause [ Time Frame: Within one-month of emergency department visit ]
  9. thromboembolic complications [ Time Frame: Within one-month of emergency department visit ]

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713101


Contacts
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Contact: Kyuseok Kim, MD +82-31-787-7572 dremkks@snubh.org
Contact: Joonghee Kim, MD +82-10-9489-3696 joonghee@me.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Kyeongi-do, Korea, Republic of
Contact: Kyuseok Kim, MD    +82-31-787-7572    dremkks@snubh.org   
Contact: Joonghee Kim, MD    +82-10-9489-3696    joonghee@me.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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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)
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01713101    
Other Study ID Numbers: B-1207-163-002
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Seoul National University Hospital:
Gastrointestinal Hemorrhage
Peptic Ulcer Hemorrhage
Hematemesis
Melena
Tranexamic acid
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranylcypromine
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
 Hemostatics
Coagulants
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs