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Portal Vein Thrombosis Relevance On Liver Cirrhosis: Italian Venous Thrombotic Events Registry

18 Years
90 Years
Open (Enrolling)
Liver Cirrhosis, Portal Vein Thrombosis

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Trial Information

Portal Vein Thrombosis Relevance On Liver Cirrhosis: Italian Venous Thrombotic Events Registry

Study Design: Prospective Longitudinal Study.

The investigators planned to assess at baseline and at scheduled follow up visits:

- Medical history collection with thrombosis risk factors evaluation;

- Clinical parameters collection;

- Upper abdomen ultrasound and portal district echo color doppler to evaluate the
presence of PVT;

- Esophagogastroduodenoscopy;

- Routine blood samples collection with plasma and urine storage;

At every follow up visit will be evaluated all relevant clinical events and will be recorded
all treatments received during the follow-up period.

Sample Size: The investigators plan to include in the study n = 1100 patients. The sample
size was calculated assuming an expected prevalence of 18% at time zero, and in order to
obtain a confidence interval 95% to prevail at time zero whose distance from the edge is
less than or equal to 3%.

Inclusion Criteria:

- Cirrhosis of any etiology and severity (including HCC)

- Signed Written Informed Consent

Exclusion Criteria:

- Extrahepatic neoplasms

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

PVT prevalence

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Francesco Violi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMI


Italy: Ethics Committee

Study ID:




Start Date:

April 2012

Completion Date:

December 2016

Related Keywords:

  • Liver Cirrhosis
  • Portal Vein Thrombosis
  • Liver Cirrhosis
  • Portal Vein Thrombosis
  • Cirrhosis Complications
  • Registry
  • Italian
  • Liver Cirrhosis
  • Fibrosis
  • Thrombosis
  • Venous Thrombosis