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

N/ACompletedNCT02069457

Jia Ji-Dong151 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

151

Conditions

Liver Cirrhosis Portal Vein Thrombosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Cirrhosis of any etiology and severity, Aged 18-80 years, Signed Informed Consent. Exclusion Criteria: 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.

Outcomes

Primary Outcomes

Presence of portal vein thrombosis

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

Time frame: 6 months

Secondary Outcomes

Cirrhosis Complications

Occurrence of digestive or other bleeding complications; Occurence of other cirrhosis-related complications ( onset or progression of oesophageal varices, ascites or refractory ascites, hepatic encephalopathy, onset of liver cancer, infections, spontaneous bacterial peritonitis, onset of hepato-renal or hepato-pulmonary syndrome)

Time frame: 1 year

Incidence of portal vein thrombosis

To estimate the incidence of new onset PVT evaluated by US in a cohort of patients with cirrhosis.

Time frame: 1 year

mortality

Overall mortality in a cohort of patients with cirrhosis without HCC

Time frame: 1 year

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes