Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dabigatran, Enoxaparin.
- Who it may be relevant to
- Registry conditions: Portal Vein Thrombosis, Liver Cirrhosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study
Overview
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)
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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
- 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.
Primary outcome measures
- Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups. [Time frame: 6 months]
Secondary outcome measures (11)
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. [Time frame: 6 months]
- Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. [Time frame: 6 months]
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups. [Time frame: 3 months]
- Rate of recurrence of Portal Vein Thrombosis at 12 months. [Time frame: 12 months]
- Adverse events in both the groups till 6-months [Time frame: 6 months]
- Change in CTP scores in both the groups over 12-months [Time frame: 12-months]
- Change in MELD scores in both the groups over 12-months [Time frame: 12-months]
- Variceal and non-variceal bleeding rates at 6-months and 12-months [Time frame: 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 [Time frame: 12-months]
- Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups. [Time frame: 12 months]
- Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age >18 years
- Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.
Exclusion criteria
- Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
- CTP >10
- Hepatocellular carcinoma
- Tumoral PVT
- Isolated gastric varices with red colour signs
- Peptic ulcer disease with large ulcers
- Pregnant or breastfeeding women
- Thrombocytopenia (platelet count <50,000/μL)
- Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
- Those not giving consent for therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Identifiers
NCT: NCT06818279 · ILBS-Cirrhosis-72