Status:
UNKNOWN
Tranexamic Acid for Acute Upper Gastrointestinal Bleed in Cirrhosis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Fibrinolytic activity ...
Detailed Description
Aim and Objective - AIM- To compare the efficacy and safety of tranexamic acid in reducing 5-day treatment failure (i.e., failure to control bleed) in patients with cirrhosis presenting with Upper GI ...
Eligibility Criteria
Inclusion
- Patients greater than 18 years of age
- Presenting with Acute UGI bleed (\< 24hrs from onset).
- Cirrhosis (Known Or suspected on clinical, biological, radiological data or the patient's history) with CTP B / C (i.e. CTP \>/=7) or ACLF (with clinical evidence of cirrhosis).
Exclusion
- Non cirrhotic patients
- Known allergy to Tranexamic Acid
- Patients with clinical evidence of DIC (Disseminated Intravascular Coagulation) like coagulopathy patches/ haematuria / uncontrolled epistaxis etc.
- Patients with Chronic Kidney Disease.
- History of recent Cerebro Vascular Accident (CVA) \[in the past 6 months\] or patients with thrombotic events \[Portal Vein thrombosis /Hepatic vein thrombosis /other sites thrombosis\]. HCC with tumour thrombosis will be included
- Any history of seizures, myocardial infarction
- Pregnancy/lactation
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04489108
Start Date
November 5 2020
End Date
April 30 2022
Last Update
January 31 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070