Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Dabigatran: Tablet Dabigatran 150 mg orally twice a day
Control Intervention1: Placebo: Placebo tablets orally twice a day
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Clinical / radiological /histologic diagnosis of cirrhosis [Childs A&B - CTP 2) Partial / total portal vein thrombosis (chronic) 3) Age- 18-70 years 4) Valid consent
Exclusion criteria
Exclusion criteria: 1) Age > 70 years 2) Presence of active infection ( 3) Use of anticoagulant drugs in the past 10 days 4) Pregnancy 5) HIV positivity 6) Recent ( 7) History of bleeding in last 42 days HCC / Other malignancy 8)Chronic kidney disease [ CrCl 9)Drug allergies 10) PVT with cavernoma formation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Recanalization of thrombus in both groupsTimepoint: 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events in both groupsTimepoint: 1 year;Change in the parameter of coagulation profileTimepoint: 3,6 and 12 months;Improvements in Child-Turcotte-Pugh (CTP) in both groupsTimepoint: 6 and 12 months;Improvements in Model for End Stage Liver Disease (MELD) Score in both groupsTimepoint: 6 and 12 months;Partial recanalization of thrombus in both groupsTimepoint: 1 Year;Prevention of secondary decompensation in both groupsTimepoint: 6 and 12 months;Reduction in clinical complications in patients with PVTTimepoint: 3,6 and 12 months;Risk of recurrences of PVT after treatmentTimepoint: 1.5 years | — |
Countries
India
Contacts
Public ContactDr Shiv Kumar Sarin
Institute of Liver and Biliary Sciences
Outcome results
None listed