MedTrace Logo

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

NCT01631877 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-06-06

No results posted yet for this study

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

Interventions

DRUG

Enoxaparin with acenocoumarol

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

OTHER

placebo

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

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01631877 on ClinicalTrials.gov