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RecruitingNCT05789654Updated Aug 3, 2023

PADUA PREDICTION SCORE in Cirrhotic Patients

An observational study in Portal Thrombosis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
132
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Portal Thrombosis

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 132 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adult cirrothic patients hospitalized in non surgical environnment

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • ongoing double anticoagulation or double antiplatelet therapy at the moment of hospitalization
  • controindications to anticoagulation therapy
  • hospitalization in surgical environnment
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
132 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. predicting venous thromboembolic risk in liver cirrhosis

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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Fondazione Policlinico Gemelli IRCCS
    Roma, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05789654
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Zocco Maria Assunta (Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 29, 2023
Start date
Sep 10, 2020
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Aug 3, 2023

Study contacts

Maria Assunta Zocco
Contact
mariaassunta.zocco@policlinicogemelli.it
00393470597805

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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