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临床试验/NCT02069457
NCT02069457已完成不适用

Prevalence and Predictive Factors of Portal Vein Thrombosis in Patients With Cirrhosis

Jia Ji-Dong1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
1
主要终点
Presence of portal vein thrombosis

研究概览

简要总结

Several studies have confirmed that patients with cirrhosis possess an imbalance in procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein C. Moreover, in the last two decades there has been an increased recognition that not only bleeding but also thrombosis complicates the clinical course of cirrhosis. The prevalence and pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The patients are going to follow up for one year and evaluate at baseline and every 6 months by liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical events will be evaluated at every follow up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cirrhosis of any etiology and severity, Aged 18-80 years, Signed Informed Consent.

排除标准

  • Hepatocellular carcinoma, other intrahepatic/extrahepatic cancers, documented history of congenital coagulation disorders, pregnancy, human immunodeficiency virus (HIV) positivity, recent (<7 d) transfusion with blood products, use of anticoagulant/antiaggregation drugs in the past 10 d.

结局指标

主要结局

Presence of portal vein thrombosis

时间窗: 6 months

To estimate the prevalence of PVT evaluated by US in a cohort of patients with liver cirrhosis of any etiology and severity.

次要结局

  • Cirrhosis Complications(1 year)
  • Incidence of portal vein thrombosis(1 year)
  • mortality(1 year)

研究者

发起方
Jia Ji-Dong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jia Ji-Dong

Director of liver research center

Beijing Friendship Hospital

研究点 (1)

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