Developing Prediction Models for Allograft Failure After Liver Transplantation
NCT05289609 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000
Last updated 2022-03-21
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 - 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 - 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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