Clinical trial NCT01631877: Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Portal Vein Thrombosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. .


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups
timeFrame: 2 years
measure: Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
timeFrame: 2 years
measure: Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences.
state: Delhi
Study officials:
References: