Portal Vein Thrombosis Clinical Trial
NCT number | NCT01631877 |
Other study ID # | ILBS- PVT-01 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | June 1, 2017 |
Verified date | December 2016 |
Source | Institute of Liver and Biliary Sciences, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. .
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver and Biliary Sciences. | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups | 2 years | ||
Secondary | Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups | 2 years | ||
Secondary | Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups | 2 years | ||
Secondary | 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 |
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