Liver Cirrhosis, Portal Vein Thrombosis
Conditions
Brief 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
Interventions
DRUGDabigatran
Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.
DRUGEnoxaparin
Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years 2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.
Exclusion criteria
1. Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications. 2. CTP \>10 3. Hepatocellular carcinoma 4. Tumoral PVT 5. Isolated gastric varices with red colour signs 6. Peptic ulcer disease with large ulcers 7. Pregnant or breastfeeding women 8. Thrombocytopenia (platelet count \<50,000/μL) 9. Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5 10. Those not giving consent for therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. | 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 | — |
| Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. | 6 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 | 12-months | Decompensation events includes any of the one ascites,HE,bleed and jaundice |
| 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 | — |
| Change in MELD scores in both the groups over 12-months | 12-months | — |
Countries
India
Contacts
Primary ContactDr Sarthak Chanana, MD
Backup ContactDr Rajan V, DM
Outcome results
None listed