Clinical trial NCT05789654: PADUA PREDICTION SCORE in Cirrhotic Patients
Official title: Accuracy of PADUA PREDICTION SCORE in Thromboembolic Risk Stratification of Cirrhotic Patients Hospitalized in a Non-surgical Environment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Portal Thrombosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult cirrothic patients hospitalized in non surgical environnment

Brief 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


Eligibility criteria: Inclusion Criteria:

* written informed consent
* age more than 18 years old
* diagnosis of liver cirrhosis
* hospitalization in a medical department

Exclusion Criteria:

* pregnancy
* ongoing double anticoagulation or double antiplatelet therapy at the moment of hospitalization
* controindications to anticoagulation therapy
* hospitalization in surgical environnment

Primary outcomes:
measure: predicting venous thromboembolic risk in liver cirrhosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
References: