Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A randomized controlled trial to study the efficacy and safety of Dabigatran in Cirrhotic patients who develop PVT.In this study the patients who meet the inclusion criteria will be randomized to either receive Dabigatran or placebo [multivitamin tablet]. Blood samples will be taken &Imaging will be done accordingly to notice progression or recanalization of PVT.The patients are followed up every 2 months up to 18 month .Then statistical analysis will be done to find whether the Dabigatran is efficacious in cirrhotic patients for recanalization of PVT.

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

Details

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

Criteria

Inclusion Criteria:

1. Clinical / radiological /histologic diagnosis of cirrhosis [Childs A&B - CTP<9]

2. Partial / total portal vein thrombosis (chronic)

3. Age- 18-70 years

4. Valid consent

Exclusion Criteria:

1. Age > 70 years

2. Presence of active infection (<2 weeks)

3. Use of anticoagulant drugs in the past 10 days

4. Pregnancy

5. HIV positivity

6. Recent (<7 days) transfusion with blood products.

7. History of bleeding in last 42 days

8. HCC / Other malignancy

9. Chronic kidney disease [ CrCl< 30]

10. Drug allergies

11. PVT with cavernoma formation