Data Collection Study From Donors and Recipients to Optimize Donor-recipient Matching in Liver Transplantation

NCT03371264 | Completed DMC

• 1 other identifier: P13639
• Study Type: observational
• Target: 9,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

A major limitation of liver transplantation is organ shortage. To avoid exposing patients to death on the waiting list, organs are used that would have been discarded few years ago. Graft allocation is regulated by the "agence de biomedecine" which establishes a national score. Each liver graft is proposed to the patient presenting the higher score. Acceptance or rejection of the graft only depends on the decision of each centre. We propose to submit a more efficient allocation model (enabling each proposed liver graft to be transplanted in the candidate whose transplantation will afford the greatest survival benefit after registration), by collecting and analysing variables from donors and candidates/recipients.

Conditions

Liver Transplantation

Keywords

Liver transplantation; Allocation process; Extended-criteria donors; Survival

Outcome Measures

Primary Outcomes (3)

• Survival analysis

  In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

  5 years

• Multi-state models

  In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

  5 years

• Decision tree analysis

  In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

  5 years

Secondary Outcomes (20)

• Number of each criterion of ECD (Donor population)

  5 years

• Percentage of each criterion of ECD (Donor population)

  5 years

• Donor scores (DRI, ELTR) (Donor population)

  5 years

• mean score (Donor population)

  5 years

• number of ECD criteria (Donor population)

  5 years

Study Arms (2)

Cohort R1 and Cohort T1

Cohort R1 (patients on the waiting list between 2009 and 2013) and Cohort T1 (transplanted patients between 2009 and 2013)

Cohort R2 and Cohort T2

Cohort R2 (patients on the waiting list in 2014) and Cohort T2 (transplanted patients in 2014)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of proposed donors and the population of patients registered on the national waiting list from 2009 to 2014 (Agence de Biomédecine)

You may qualify if:

• Liver transplant candidates : All adult LT candidates listed on the French wait list between 2009 and 2014 and followed prospectively by the mean yearly follow-up under the control of ABM.
• Donors : all adults donors registered over the same 2009-2014 period, including donors whose livers were procured and transplanted, whose liver were procured and discarded, and donors in whom liver was not harvested.

You may not qualify if:

• Pediatric recipients
• Pediatric donors

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence de La Biomédecine: collaborator

Study Officials

• Cyrille Feray, MD/PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 13, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share