About this trial
Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.
Disqualifiers
Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
CTP >10
Hepatocellular carcinoma
Tumoral PVT
Trial design
Parallel
Treatments tested in this trial
Dabigatran
DrugDabigatran 150 mg BD fixed dose to be given for duration of 6 months.
Enoxaparin
DrugEnoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.
Secondary outcomes
Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.
Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.
Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups.
Rate of recurrence of Portal Vein Thrombosis at 12 months.
Sponsors and contacts
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