Portal Vein Thrombosis
Conditions
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. .
Interventions
DRUGEnoxaparin with acenocoumarol
enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR
OTHERplacebo
injection placebo will be given for 5 days along with placebo tablets
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups | 2 years |
| Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups | 2 years |
| Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups | 2 years |
| 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. | 2 years |
Countries
India
Outcome results
None listed