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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Feb 4, 2025

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ClinConnect Summary

This clinical trial is looking at two medications, dabigatran and enoxaparin, to see which one works better and is safer for patients who have portal vein thrombosis (PVT) and liver cirrhosis. PVT is a condition where a blood clot forms in the portal vein, which can lead to serious complications, especially in people with liver issues. The study will follow participants for 6 months to see if either medication can effectively clear the clot and improve their health.

To be eligible for this trial, participants need to be over 18 years old and have been diagnosed with cirrhosis and PVT within the past 6 months. However, certain individuals will not be able to participate, such as those with active bleeding, recent major surgery, or severe liver disease. While the trial is not open for recruitment yet, anyone who is eligible and interested can expect to receive either dabigatran or enoxaparin and will be monitored closely for safety and effectiveness throughout the study. This research is important because it aims to provide clearer guidance on the best treatment options for patients with these conditions.

Gender

ALL

Eligibility criteria

• 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