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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin | Active Comparator | Enoxaparin Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months. |
|
| Dabigatran | Experimental | Dabigatran 150 mg BD fixed dose to be given for duration of 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | Dabigatran 150 mg BD fixed dose to be given for duration of 6 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. | 6 months | |
| Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarthak Chanana, MD | Contact | 01146300000 | xs2sarthak@gmail.com | |
| Dr Rajan V, DM | Contact | 01146300000 | rajanvf40@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Enoxaparin |
| Drug |
Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months. |
|
| Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups. | 3 months |
| Rate of recurrence of Portal Vein Thrombosis at 12 months. | 12 months |
| Adverse events in both the groups till 6-months | 6 months |
| Change in CTP scores in both the groups over 12-months | 12-months |
| Change in MELD scores in both the groups over 12-months | 12-months |
| Variceal and non-variceal bleeding rates at 6-months and 12-months | 6-months and 12-months |
| Number of patients with worsening of decompensation events and new onset decompensation events in the two study groups till 12-months | Decompensation events includes any of the one ascites,HE,bleed and jaundice | 12-months |
| Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups. | 12 months |
| Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups. | 12 months |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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