Clinical Trial Summary
Primary objective: to evaluate the predictive role of Prediction Score on the risk of
developing venous thromboembolism in patients with liver cirrhosis admitted to non-surgical
wards.
Secondary objectives:
- To estimate the prevalence and incidence of venous thromboembolism in patients with
liver cirrhosis admitted to non-surgical wards
- To calculate the prevalence in the same subset of patients of major bleeding (defined as
bleeding resulting in the patient's death, a drop in hemoglobin > 2g/L, the need to
transfuse > 2 units of packed red blood cells or bleeding into a critical organ/space
including the intracranial, retroperitoneal, intraocular, adrenal, spinal, pericardial
districts) related to the application or not of thromboprophylaxis measures
(pharmacological and mechanical) Study design: The study is single center and it will be
divided into two parts, a first retrospective part and a second prospective case control
study.
Methods: adult patients with liver cirrhosis admitted in Internal Medicine and
Gastroenterology Unit of Policlinico Agostino Gemelli will be enrolled in the prospective
study. For the retrospective part of the study, data about cirrhotic patients hospitalized in
non-surgical departments of Policlinico Agostino Gemelli will be collected. Exclusion
criteria will be hospitalization in surgical wards or intensive care units, patients with
active bleeding at the time of admission, patients hospitalized for liver transplantation,
anticoagulant therapy at therapeutic dosage at the time of admission for indications other
than liver cirrhosis (e.g. personal history of thromboembolic events, atrial
fibrillation/flutter or mechanical heart valves), contraindications to anticoagulant
prophylaxis (recent or ongoing bleeding, creatinine clearance assessed by EPI-CKD method < 15
ml/min, platelet count < 50 x 10^9/L), patients hospitalized as elective regimen to perform
invasive procedures that contraindicate anticoagulant prophylaxis (e.g. liver biopsy, local
treatment of liver neoplasms, ligation of oesophageal varices), double antiplatelet therapy,
pregnancy
