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

• Status: Withdrawn
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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. .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Acenocoumarol; Enoxaparin

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