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

Institute of Liver and Biliary Sciences, India

Overview

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. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Portal Vein Thrombosis

Interventions

Enoxaparin with acenocoumarolDRUG

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

placeboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Liver and Biliary Sciences.

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Proportions of patients who will achieve Recanalization of thrombus (complete i.e No thrombus is seen or partial i.e up to 50% of the lumen become patent.)on oral anticoagulant acenocoumarol during the study period of 2 year from randomization.

Time frame: 2 years

Secondary Outcomes

Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups

Time frame: 2 years

Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups

Time frame: 2 years

Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups

Time frame: 2 years

Proportions of patients will show decrease in hepatic decompensation i.e hepatic encephalopathy,ascites,hepato renal syndrome,variceal bleed,jaundice and coagulopathy in both groups.

Time frame: 2 years

Data from ClinicalTrials.gov

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