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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069457
• Other study ID #: BJFH20140220
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: July 26, 2015
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jia Ji-Dong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	1 year	No
Secondary	Incidence of portal vein thrombosis	To estimate the incidence of new onset PVT evaluated by US in a cohort of patients with cirrhosis.	1 year	No
Secondary	mortality	Overall mortality in a cohort of patients with cirrhosis without HCC	1 year	No