Tranexamic Acid for Upper Gastrointestinal Bleeding

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000694

Enrollment

414

Registered

2013-03-05

Start date

2013-01-07

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Tranexamic acid intravenous administration is the main intervention of this study. Therefore in study group, the drug will be admistered as follows. 1) 1g IV bolus over 10 minutes 2) 1g slow

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chief complaint of hematemesis, melena or hematochezia 2. and objective signs of upper gastrointestinal bleeding

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients requiring early endoscopic treatment	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJoonghee Kim

Seoul National University Bundang Hospital

Outcome results