Tranexamic Acid for Upper Gastrointestinal Bleeding

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0000694
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 414

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
i) Increased thromboembolic risk
a. History of thromboembolic disease
b. Alleged inherited thrombophilic disorders
c. Malignancy (except those cured and has not recurred more than two years)
d. Nephrotic syndrome
e. Estrogen use
f. Pregnancy
g. HIT, APA
ii)High-risk for cardioembolism
a. Underlying structural heart disease where anticoagulation is indicated
b. Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter)
iii) Possibilities of ongoing DIC
a. Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature > 38 degree)
b. Any malignancy except those cured and has not recurred more than two years
iv) Patients with history or presence of subarachnoid hemorrhage
v) Acquired color vision impairment, visual loss and retinal venous and arterial occlusions
vi) 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

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients requiring early endoscopic treatment

Secondary Outcome Measures

Name	Time	Method
Endoscopic signs of bleeding;thromboembolic complications;Need for urgent endoscopy;Endoscopic procedure time;Endoscopic procedure difficulty;Length of stay;Need for transfusion;Need for surgery/angiointervention;rate of recurrent bleeding;death of any cause