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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Portal Vein Thrombosis

Treatments: Drug: Enoxaparin with acenocoumarol; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01631877

ILBS- PVT-01

Details and patient eligibility

About

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. .

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

enoxaparin with acenocoumarol

Experimental group

Description:

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.

Treatment:

Drug: Enoxaparin with acenocoumarol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo