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

Last updated: February 4, 2025
Sponsor: Institute of Liver and Biliary Sciences, India
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Vascular Diseases

Scar Tissue

Venous Thrombosis

Treatment

Enoxaparin

Dabigatran

Clinical Study ID

NCT06818279
ILBS-Cirrhosis-72
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >18 years

  2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis/SymptomaticPVT/PVT in potential transplant recipient.

Exclusion

Exclusion Criteria:

  1. Contraindications to anticoagulant therapy, such as active bleeding, recent majorsurgery, 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 Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Enoxaparin
Phase: 2/3
Study Start date:
January 31, 2025
Estimated Completion Date:
January 31, 2026

Study 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)

    13. Complete history and physical examination

    14. Pattern and number of decompensation

    15. MELD, CTP, APRI, ALBI Score

    16. Hemogram, Kidney function test, Liver function test, INR

    17. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen

Connect with a study center

  • Institute of Liver & Biliary Sciences (ILBS)

    New Delhi, Delhi 110070
    India

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.