Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
enoxaparin with acenocoumarol
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.
干预措施: Enoxaparin with acenocoumarol (Drug)
Placebo
Injection placebo will be given for 5 days along with placebo tablets.
干预措施: placebo (Other)
结局指标
主要结局
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.
时间窗: 2 years
次要结局
- Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)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)
- 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)