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

NCT02069457 | Completed

• 1 other identifier: BJFH20140220
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis; Portal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Cirrhosis Complications

  1 year

• Incidence of portal vein thrombosis

  1 year

• mortality

  1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis of any etiology and severity

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jia Ji-Dong: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jidong Jia, Doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of liver research center

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 24, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

CN (1)