Tranexamic Acid for Upper Gastrointestinal Bleeding

Acute Upper Gastrointestinal Hemorrhage Clinical Trial

— TAUGIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713101
• Other study ID #: B-1207-163-002
• Status: Recruiting
• Phase: Phase 3
• First received: October 18, 2012
• Last updated: May 14, 2014
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: Kyuseok Kim, MD
• Phone: +82-31-787-7572
• Email: dremkks[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Hemorrhage
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Early intravenous tranexamic acid administration
Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.
• placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Kyeongi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	Proportion of patients requiring early endoscopic treatment		Within 24 hours of emergency department visit	No
Secondary	Endoscopic signs of bleeding		Within 24 hours of emergency department visit	No
Secondary	Length of stay		Within one-month of emergency department visit	Yes
Secondary	Need for urgent endoscopy		Within 24 hours of emergency department visit	No
Secondary	Endoscopic procedure time/difficulty		Within 24 hours of emergency department visit	No
Secondary	Need for transfusion		Within one-month of emergency department visit	Yes
Secondary	Need for surgery/angiographic intervention		Within one-month of emergency department visit	Yes
Secondary	rate of recurrent bleeding		Within one-month of emergency department visit	Yes
Secondary	death of any cause		Within one-month of emergency department visit	Yes
Secondary	thromboembolic complications		Within one-month of emergency department visit	Yes