Risk and Protective Factors for Relapse to Alcohol Use in Patients With Liver Disease Undergoing Liver Transplantation

NCT06749990 | Recruiting

• 1 other identifier: RICADUTA
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, monocentric study, consisting of both a retrospective and a prospective component. The aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (ARLD) who have undergone orthotopic liver transplantation (OLT).

Conditions

Alcohol Related Liver Disease; Orthotopic Liver Transplantation

Outcome Measures

Primary Outcomes (4)

• alcohol relapse rate

  To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol relapse rate

  7 years

• alcohol recurrence rate

  To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol recurrence rate

  7 years

• Clinical data to assess the risk of alcohol relapse

  Collection of clinical data on liver disease through routine visits to assess the risk of alcohol relapse at 12 months post-OLT

  7 years

• psychiatric evaluation to assess the risk of alcohol relapse

  Administration of a clinimetric assessment composed of psychometric, self-assessment tests, already validated and widely used in the literature

  7 years

Secondary Outcomes (2)

• Impact of alcohol relapse/recurrence on liver transplant outcomes

  7 years

• Identifying Risk and Protective Factors for Alcohol Relapse

  7 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients in the retrospective cohort include those diagnosed with ARLD and exotoxicity-related components who underwent liver transplantation and were followed at the Internal Medicine Department for the treatment of severe organ failure at IRCCS AOUBO between 01/01/2017 and 31/12/2022. The patients in the prospective cohort are those diagnosed with ARLD or with exotoxicity-related etiologies who are referred to the Internal Medicine Department for the treatment of severe organ failure.

You may qualify if:

• Patients who have signed the informed consent
• Candidates for liver transplantation due to liver disease with alcohol-related etiology (either mono- or multifactorial)
• For the retrospective part: patients who underwent OLT for ARLD during the time frame 2017-2022

You may not qualify if:

• Major psychopathologies and active psychoses

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Maria Cristina Morelli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Morelli, MD

CONTACT

0512144248; mariacristina.morelli@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 27, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 27, 2024

Record last verified: 2024-11

Locations

IT (1)