Effect of Dabigatran drug versus Enoxaparin drug in Liver Cirrhosis (Disease).

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081072

Enrollment

120

Registered

2025-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Dabigatran: Dabigatran 150 mg BD fixed dose to be given for duration of 6 months. Control Intervention1: Enoxaparin: Enoxaparin Treatment would be given with 1 mg per Kg (100IU per Kg)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years 2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.

Exclusion criteria

Exclusion criteria: 1. Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications. 2. CTP more than 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 less than 50,000 per micro L) 9. Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5 10. Those not giving consent for therapy

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Dabigatran and enoxaparin in achieving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months. Timepoint: 6 months	—

Secondary

Measure	Time frame
Rate of partial and complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groupsTimepoint: 6 months;Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groupsTimepoint: 3 months;Rate of recurrence of Portal Vein Thrombosis at 12 months.Timepoint: 12 months;Adverse events in both the groups till 6-monthsTimepoint: 6 months;Change in CTP scores and MELD scores in both the groups over 12-monthsTimepoint: 12 months;Variceal and non-variceal bleeding rates at 6-months and 12-months.Timepoint: 12 months;Worsening of decompensation events and new onset decompensation events in the two study groups till 12-months.Timepoint: 12 months;To define predictors of recanalisation at 6 months and rethrombosis at 12 months.Timepoint: 12 months	—

Measure

Time frame

Rate of partial and complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groupsTimepoint: 6 months;Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groupsTimepoint: 3 months;Rate of recurrence of Portal Vein Thrombosis at 12 months.Timepoint: 12 months;Adverse events in both the groups till 6-monthsTimepoint: 6 months;Change in CTP scores and MELD scores in both the groups over 12-monthsTimepoint: 12 months;Variceal and non-variceal bleeding rates at 6-months and 12-months.Timepoint: 12 months;Worsening of decompensation events and new onset decompensation events in the two study groups till 12-months.Timepoint: 12 months;To define predictors of recanalisation at 6 months and rethrombosis at 12 months.Timepoint: 12 months

—

Countries

India

Contacts

Public ContactDr V Rajan

Institute of Liver and Biliary Sciences

rajanvf40@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026