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;
- 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%.
Observational Model: Cohort, Time Perspective: Prospective
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.
Francesco Violi, MD
Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMI
Italy: Ethics Committee