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

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 Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis; Portal Vein Thrombosis
• Intervention / Treatment: Drug: Enoxaparin; Drug: Dabigatran

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dr Sarthak Chanana, MD; Phone Number: 01146300000; Email: xs2sarthak@gmail.com
• Study Contact Backup: Name: Dr Rajan V, DM; Phone Number: 01146300000; Email: rajanvf40@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences (ILBS)
      • Contact: Dr Sarthak Chanana, MD; Phone Number: 01146300000; Email: xs2sarthak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enoxaparin; Enoxaparin Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.	Drug: Enoxaparin; Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.
Experimental: Dabigatran; Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.	Drug: Dabigatran; Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Digestive System Diseases; Liver Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Fibrosis; Liver Cirrhosis; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Antithrombins; Serine Proteinase Inhibitors; Dabigatran; Enoxaparin
• Other Study ID Numbers: ILBS-Cirrhosis-72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No