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ElastOLT: Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05793203
Collaborator
(none)
100
Enrollment
1
Location
89.8
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD.

The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
    Actual Study Start Date :
    Jul 6, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Early Allograft dysfunction (EAD) [2 weeks from Liver transplantation]

      Olthoff criteria: bilirubina≥ 10 mg/dL in 7th post-operative day, international normalized ratio (INR) ≥ 1.6 in 7th post-operative day 7; ALT or AST> 2000 IU/L during the first 7 days after liver transplantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients eligible for liver transplantation following National and International Guidelines
    Exclusion Criteria:

    • No agreement or inability to give informed consent

    • Re-transplant patients

    • Liver transplant in fulminant hepatitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy 00181

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    • Study Chair: Antonio Liguori, MD, Catholic University of the Sacred Heart

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05793203
    Other Study ID Numbers:
    • 4176
    First Posted:
    Mar 31, 2023
    Last Update Posted:
    Mar 31, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Postoperative Complications

    Study Results

    No Results Posted as of Mar 31, 2023