drugset / Trial / NCT01631877

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

NCT01631877

RandomizedParallel-groupDouble-blindTreatment

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. .

Timeline

Start
2012-06
Primary completion
2017-06-01
Completion
2017-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject acenocoumarol Unknown 2 mg
Background Enoxaparin sodium Other / unclassified 100 ug/kg Subcutaneous