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OpenTrials
Completed

NCT Number: NCT02069457

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

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Vein Thrombosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of portal vein thrombosis

    Time frame: 6 months

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

Secondary outcomes

  1. Cirrhosis Complications

    Time frame: 1 year

    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)

  2. Incidence of portal vein thrombosis

    Time frame: 1 year

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

  3. mortality

    Time frame: 1 year

    Overall mortality in a cohort of patients with cirrhosis without HCC

Sponsors and collaborators

Lead sponsor

Jia Ji-Dong

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 24, 2014
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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