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NCT Number: NCT06818279

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

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.

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Key information

Conditions

Portal Vein Thrombosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location contact

Dr Sarthak Chanana, MD

CONTACT

[email protected]

01146300000

About this study

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:
  • Complete history and physical examination
  • Etiology of cirrhosis
  • Presenting symptoms
  • Severity of ascites, Jaundice
  • Pattern and number of prior decompensation
  • UGIE and variceal status
  • Complete physical evaluation
  • Hemogram, Kidney function test, Liver function test, INR
  • Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
  • Fibroscan-liver and spleen
  • 2D-ECHO, ECG
  • AFP At follow-up (1month, 3 month, 6 month, 9 month 12month)

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  • Complete history and physical examination
  • Pattern and number of decompensation
  • MELD, CTP, APRI, ALBI Score
  • Hemogram, Kidney function test, Liver function test, INR
  • Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dabigatran

Drug

Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.

Enoxaparin

Drug

Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.

Primary outcomes

  1. Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.

    Time frame: 6 months

Secondary outcomes

  1. Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.

    Time frame: 6 months

  2. Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.

    Time frame: 6 months

  3. Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups.

    Time frame: 3 months

  4. Rate of recurrence of Portal Vein Thrombosis at 12 months.

    Time frame: 12 months

  5. Adverse events in both the groups till 6-months

    Time frame: 6 months

  6. Change in CTP scores in both the groups over 12-months

    Time frame: 12-months

  7. Change in MELD scores in both the groups over 12-months

    Time frame: 12-months

  8. Variceal and non-variceal bleeding rates at 6-months and 12-months

    Time frame: 6-months and 12-months

  9. 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

    Decompensation events includes any of the one ascites,HE,bleed and jaundice

  10. Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups.

    Time frame: 12 months

  11. Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Rajan V, DM

CONTACT

[email protected]

01146300000

Dr Sarthak Chanana, MD

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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