Tranexamic Acid for Acute Upper Gastrointestinal Bleed in Cirrhosis

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 of the epithelial surfaces and of the submucosal blood vessels may interfere with hematemesis and even delay healing of ulcers. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. Tranexamic Acid in patients with acute Upper Gastrointestinal bleed have been shown to prevent re bleed in few studies when combined with standard medical management (which generally comprises of initial fluid resuscitation, intravenous PPI , splanchnic vasoconstrictors, blood transfusions and coagulopathy corrections as per lab parameters) but no randomized placebo controlled trial has been done. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB as compared to placebo in patients with cirrhosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Patients greater than 18 years of age

2. Presenting with Acute UGI bleed (< 24hrs from onset).

3. 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 Criteria:

1. Non cirrhotic patients

2. Known allergy to Tranexamic Acid

3. Patients with clinical evidence of DIC (Disseminated Intravascular Coagulation) like coagulopathy patches/ haematuria / uncontrolled epistaxis etc.

4. Patients with Chronic Kidney Disease.

5. 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

6. Any history of seizures, myocardial infarction

7. Pregnancy/lactation