PADUA PREDICTION SCORE in Cirrhotic Patients

NCT05789654 | Unknown

• 1 other identifier: 3394
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Portal Thrombosis

Outcome Measures

Primary Outcomes (1)

• predicting venous thromboembolic risk in liver cirrhosis

  evaluating Padua Prediction Score role in predicting venous thromboembolic risk in liver cirrhosis

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult cirrothic patients hospitalized in non surgical environnment

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, Italy

RECRUITING

Central Study Contacts

Maria Assunta Zocco

CONTACT

00393470597805; mariaassunta.zocco@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: September 10, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

IT (1)