Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
研究概览
简要总结
The purpose of this study is to determine whether Apixaban is effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection
详细描述
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, and be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. The Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients at baseline, on postoperative months (POD) 7, at postoperative months (POM) 1, 3, and 6. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done as per the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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 of any etiology
- •Splenomegaly with secondary hypersplenism
- •Bleeding portal hypertension
- •No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
- •Informed consent to participate in the study
排除标准
- •Hepatocellular carcinoma or any other malignancy,
- •Hypercoagulable state other than the liver disease related
- •DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- •Child - Pugh C
- •Recent peptic ulcer disease
- •History of Hemorrhagic stroke
- •Uncontrolled Hypertension
- •Human immunodeficiency virus (HIV) infection
研究组 & 干预措施
Apixaban group
From postoperative day 3, Patients will receive oral Dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.
干预措施: Apixaban 2.5 MG (Drug)
Apixaban group
From postoperative day 3, Patients will receive oral Dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.
干预措施: Dipyridamole 25Mg Tab (Drug)
Apixaban group
From postoperative day 3, Patients will receive oral Dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.
干预措施: subcutaneous Low Molecular Weight Heparin (Drug)
结局指标
主要结局
Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
时间窗: 6 months
Proportion of participants with Main and intrahepatic branches of portal vein thrombosis by ultrasound evaluation
次要结局
- Proportion of participants with Splenic vein thrombosis(6 months)
- Proportion of participants with Mesenteric vein thrombosis(6 months)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital