Status:
UNKNOWN
Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Portal Vein Thrombosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 eith...
Detailed Description
Study population -All the patients of cirrhosis of liver patients visiting to ILBS and diagnosed to have non tumor portal vein thrombosis will be enrolled in the study. Study Design - A Placebo Contr...
Eligibility Criteria
Inclusion
- Clinical / radiological /histologic diagnosis of cirrhosis \[Childs A\&B - CTP\<9\]
- Partial / total portal vein thrombosis (chronic)
- Age- 18-70 years
- Valid consent
Exclusion
- Age \> 70 years
- Presence of active infection (\<2 weeks)
- Use of anticoagulant drugs in the past 10 days
- Pregnancy
- HIV positivity
- Recent (\<7 days) transfusion with blood products.
- History of bleeding in last 42 days
- HCC / Other malignancy
- Chronic kidney disease \[ CrCl\< 30\]
- Drug allergies
- PVT with cavernoma formation
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04433481
Start Date
June 20 2020
End Date
May 31 2022
Last Update
August 25 2021
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070