Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients：A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Recanalization Rate
研究概览
简要总结
The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
详细描述
Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to partial or complete thrombosis formed in the lumen of portal vein or/and branches of it. Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although numerable studies have reported that anticoagulation therapy is effective, while a majority of them were respective and a few took control into consideration. In addition, no agreement has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant therapy needs more prospective randomized controlled trial to be investigated.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography
排除标准
- •Cavernous transformation of the portal vein
- •Uncontrolled active bleeding
- •Platelet count lower than 10*10^9/L
- •Creatinine more than 170 mmol/L
- •Ongoing or received antithrombotic/thrombolytic treatment
- •Primary thrombophilia
- •Budd-Chiari syndrome
- •Pregnancy or breast-feeding period
- •Severe cardiopulmonary diseases
- •Severe systemic infection or sepsis
- •Inability to sign informed consent
研究组 & 干预措施
nadroparin calcium-warfarin sequential therapy group
nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months
干预措施: Nadroparin calcium, warfarin (Drug)
结局指标
主要结局
Recanalization Rate
时间窗: 6 months
For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins.
次要结局
- Rate of Bleeding(6 months)