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%.