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

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:
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Placebo Comparator: Placebo group
Normal saline (placebo) administration instead of tranexamic acid solution
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Drug: placebo |
- Proportion of patients requiring early endoscopic treatment [ Time Frame: Within 24 hours of emergency department visit ]
- 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 ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chief complaint of hematemesis, melena or hematochezia
- and objective signs of upper gastrointestinal bleeding
Exclusion Criteria:
- Pregnant woman, age less than 18
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Patients whose use of the study drug is contraindicated
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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
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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)
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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
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- Previous history of variceal bleeding
- Cases where informed consent is unobtainable

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
Contact: Kyuseok Kim, MD | +82-31-787-7572 | dremkks@snubh.org | |
Contact: Joonghee Kim, MD | +82-10-9489-3696 | joonghee@me.com |
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 |
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) |
Responsible Party: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01713101 History of Changes |
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:
Hemorrhage Gastrointestinal Hemorrhage Pathologic Processes Gastrointestinal Diseases Digestive System Diseases Tranexamic Acid |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |