NCT06818279

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

Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study population: Cirrhosis with portal vein thrombosis within 6 months of diagnosis of portal vein thrombus Study design - A prospective, randomized, single center open label study Block Randomization, block size - 10 Study site - Department of Hepatology, ILBS, New Delhi from The study will be conducted on the consecutive patients with liver cirrhosis with portal vein thrombosis. Study period -1 year Monitoring and assessment * At enrollment: 1. Complete history and physical examination 2. Etiology of cirrhosis 3. Presenting symptoms 4. Severity of ascites, Jaundice 5. Pattern and number of prior decompensation 6. UGIE and variceal status 7. Complete physical evaluation 8. Hemogram, Kidney function test, Liver function test, INR 9. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen 10. Fibroscan-liver and spleen 11. 2D-ECHO, ECG 12. AFP At follow-up (1month, 3 month, 6 month, 9 month 12month) <!-- --> 1. Complete history and physical examination 2. Pattern and number of decompensation 3. MELD, CTP, APRI, ALBI Score 4. Hemogram, Kidney function test, Liver function test, INR 5. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen

Conditions

• Portal Vein Thrombosis
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Dabigatran	Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.
DRUG	Enoxaparin	Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.

Timeline

• Start date: 2025-01-31
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: India