Tranexamic Acid for Upper Gastrointestinal Bleeding

NCT ID: NCT01713101

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-08-31

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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

Conditions

Acute Upper Gastrointestinal Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Early intravenous tranexamic acid administration

Intervention Type: DRUG

Initial history taking and physical examination --\> enrollment --\> 1g bolus over 10 minutes followed slow infusion over 8 hours.

Placebo group

Normal saline (placebo) administration instead of tranexamic acid solution

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Early intravenous tranexamic acid administration

Initial history taking and physical examination --\> enrollment --\> 1g bolus over 10 minutes followed slow infusion over 8 hours.

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

tranexamic acid administration; transamine administration; antifibrinolytics administration

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyuseok Kim, MD

Role: STUDY_DIRECTOR

Professor, department of emergency medicine

Sang Hyub Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, department of internal medicine (gastroenterology)

Cheol Min Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, department of internal medicine (gastroenterology)

Locations

Seoul National University Bundang Hospital

Seongnam-si, Kyeongi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kyuseok Kim, MD

Role: CONTACT

dremkks@snubh.org

+82-31-787-7572

Joonghee Kim, MD

Role: CONTACT

joonghee@me.com

+82-10-9489-3696

Facility Contacts

Kyuseok Kim, MD

Role: primary

dremkks@snubh.org

+82-31-787-7572

Joonghee Kim, MD

Role: backup

joonghee@me.com

+82-10-9489-3696

Other Identifiers

B-1207-163-002

Identifier Type: -

Identifier Source: org_study_id