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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069457

Enrollment

151

Registered

2014-02-24

Start date

2013-12-31

Completion date

2015-06-30

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Portal Vein Thrombosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Presence of portal vein thrombosis	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

Measure	Time frame	Description
Cirrhosis Complications	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)
Incidence of portal vein thrombosis	1 year	To estimate the incidence of new onset PVT evaluated by US in a cohort of patients with cirrhosis.
mortality	1 year	Overall mortality in a cohort of patients with cirrhosis without HCC

Countries

China

Outcome results