Initiation of NWS Anticoagulation Therapy After Oesophageal Variceal Band Ligation Was Safe in Portal Vein Thrombosis Patients With Cirrhosis and Acute Variceal Bleeding: A Multi-central Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- rate of overall recanalization
研究概览
简要总结
The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.
详细描述
Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.
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
- •clinical diagnosis of cirrhosis
- •Portal hypertension with esophageal and gastric varices
- •diagnosis of PVT by imaging examination
- •undergo endoscopic therapy
排除标准
- •older than 75 years
- •uncontrolled active bleeding
- •hepatocellular carcinoma or other extrahepatic malignancy
- •on-going or received antithrombotic/thrombolytic treatment
- •previous treatment with TIPSS
- •cavernous transformation of the portal vein
- •platelet count lower than 10*10 ^ 9/L, creatinine more than 170 μmol/L
- •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
NWS group
nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months
干预措施: nadroparin calcium-warfarin sequential anticoagulation (Drug)
结局指标
主要结局
rate of overall recanalization
时间窗: 6-month
the sum of the fraction of patients who had complete or partial recanalization
rate of bleeding
时间窗: 6-month
rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events
次要结局
未报告次要终点