Developing Prediction Models for Allograft Failure After Liver Transplantation

NCT05289609 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2022-03-21

No results posted yet for this study

Summary

Prompt identification of allograft failure (AF) is highly desirable to address patients to liver retransplantation, in order to maximize results and preserve patients safety.

Recently, sophisticated kinetic models became available, offering the possibility to predict 90-day AF with unprecedented accuracy, by computing data from the first 10 days after liver transplant (LT).

The growing utilization of extended criteria and cardiac death donors stimulates the transplant community to further refine such predictive models and validate them on a larger scale population of patients across the nations.

This study aims to develop new algorithms for the timely prediction of AF at 90 and 365 days using a prospective international cohort from high-volume centers, to validate them on a large retrospective cohort, to identify the best time for retransplantation, to stratify the risk of AF according to the graft type (i.e. DBD, ECD, DCD, LD), to weigh the effect of risk-mitigation strategies, and to assess the correlation with post-LT morbidity and mortality.

Conditions

  • Liver Transplant Disorder

Interventions

PROCEDURE

Liver Transplantation

Individuals with end-stage liver disease will be subjected to liver transplantation from deceased or living donors

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER
  • University Hospital Padova

    collaborator OTHER
  • Mayo Clinic

    collaborator OTHER
  • Hospital Italiano de Buenos Aires

    collaborator OTHER
  • Tokyo Women's Medical University

    collaborator OTHER
  • Hospital Universitario La Paz

    collaborator OTHER
  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • University of Roma La Sapienza

    collaborator OTHER
  • University of Massachusetts, Worcester

    collaborator OTHER
  • The Cleveland Clinic

    collaborator OTHER
  • Dr. Rela Institute & Medical Centre

    collaborator UNKNOWN
  • University of Toronto

    collaborator OTHER
  • Universidade Federal do Paraná

    collaborator OTHER
  • Royal Infirmary of Edinburgh

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Vatche Agopian · University of California, Los Angeles

  • Alfonso W Avolio · Fondazione Policlinico universitario Agostino Gemelli IRCCS, Rome, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-12-01
Completion
2024-04-01

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • India
  • Italy
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05289609 on ClinicalTrials.gov