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PADUA PREDICTION SCORE in Cirrhotic Patients

Accuracy of PADUA PREDICTION SCORE in Thromboembolic Risk Stratification of Cirrhotic Patients Hospitalized in a Non-surgical Environment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05789654
Enrollment
132
Registered
2023-03-29
Start date
2020-09-10
Completion date
2024-12-31
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Thrombosis

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

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
predicting venous thromboembolic risk in liver cirrhosis12 monthsevaluating Padua Prediction Score role in predicting venous thromboembolic risk in liver cirrhosis

Countries

Italy

Contacts

Primary ContactMaria Assunta Zocco
mariaassunta.zocco@policlinicogemelli.it00393470597805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026