Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver

NCT ID: NCT01631877

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-06-01

Brief Summary

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (acenocoumarol) or placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj. Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3 monthly the Doppler screening for recanalization of portal vein thrombus will be done with monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus re-canalization.Then one year drug free monitoring will be done in both the groups as per the primary or secondary outcome. .

Conditions

Portal Vein Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

enoxaparin with acenocoumarol

Patients will receive enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg with titration of dose to maintain a target INR of 2-3.intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR.After achieving the target INR this is to be repeated every 4th weekly. The Doppler Ultra Sonography screening will be done every 3monthly to assess the recanalization of portal vein thrombus but the medications will be continue for one year irrespective of recanalization.

Group Type: EXPERIMENTAL

Enoxaparin with acenocoumarol

Intervention Type: DRUG

enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR

Placebo

Injection placebo will be given for 5 days along with placebo tablets.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

injection placebo will be given for 5 days along with placebo tablets

Interventions

Enoxaparin with acenocoumarol

enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR

Intervention Type: DRUG

placebo

injection placebo will be given for 5 days along with placebo tablets

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A clinical, radiological or histologic diagnosis of cirrhosis
• Partial or total Portal vein thrombus (evidence of chronic thrombus)
• Informed consent to participate in the study

Exclusion Criteria

• Acute thrombus in Portal vein
• Hepatocellular carcinoma or any other malignancy,
• Hypercoagulable state other than the liver disease related
• DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
• Base line INR >2
• Child Turcott Pugh score>11
• Recent peptic ulcer disease
• History of Hemorrhagic stroke
• Pregnancy.
• Uncontrolled Hypertension
• Age>70 yrs
• Non responders to beta-blocker requiring Endoscopic Variceal Ligation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver and Biliary Sciences.

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS- PVT-01

Identifier Type: -

Identifier Source: org_study_id