The Effect of Rifaximin on Portal Vein Thrombosis in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Changes of portal vein thrombosis
研究概览
简要总结
The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients
详细描述
Portal vein thrombosis is not an uncommon complication in cirrhotic portal hypertension, which lead to a poor prognosis in endoscopic management of variceal bleeding. Evidence indicated that enoxaparin prevented PVT and liver decompensation via decreased rates of bacterial infections and lowered the potent inflammatory mediators such as interleukin-6. Rifaximin is a broad-spectrum antibiotic that exerts endotoxin-lowering and anti-inflammatory effects.
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
- •18 y.o. ≤age≤75 y.o
- •Cirrhotic patients had CTA confirmed portal vein trombosis
- •D-dimer no more than five times the normal upper limit
排除标准
- •age <18 y.o. or age > 75 y.o.
- •had portal cavernoma
- •received anticoagulation treatment in the past 6 months
- •splenectomy
- •Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
- •Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
- •Acute variceal bleeding within 5 days.
- •Use of other antibiotics in the past 2 weeks
- •Acute portal vein thrombosis
研究组 & 干预措施
Rifaximin treatment group
Rifaximin 400mg bid for 8 weeks
干预措施: Rifaximin (Drug)
结局指标
主要结局
Changes of portal vein thrombosis
时间窗: 8 weeks
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)
次要结局
- Changes of portal vein thrombosis(6 months)
- All clinical events(6 months)
研究者
Shiyao Chen
Professor
Shanghai Zhongshan Hospital