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

Completed

• Conditions: Liver Transplantation

• Registration Number: NCT03371264
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Primary Completion: 2018-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

• 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.

Exclusion Criteria

• Pediatric recipients
• Pediatric donors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decision tree analysis	5 years	In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models
Survival analysis	5 years	In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models
Multi-state models	5 years	In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

Secondary Outcome Measures

Name	Time	Method
deaths on the waiting list (Candidate population)	5 years
drop-outs for worsening (Candidate population)	5 years	Description of events occurring on waiting list
number of ECD criteria (Donor population)	5 years
graft failure (Donor population)	5 years
Number of each criterion of ECD (Donor population)	5 years
Percentage of each criterion of ECD (Donor population)	5 years
epidemiological characteristics (Candidate population)	5 years
indication for transplantation (Candidate population)	5 years
number of drop-outs for improvement (Candidate population)	5 years
mean score (Donor population)	5 years
frequency of ECD criteria (Donor population)	5 years
mean age of donors (Donor population)	5 years
grafts with correct primary function (Donor population)	5 years
Proportion of early deaths after transplantation (Candidate population)	5 years
median time of occurrence (Candidate population)	5 years	Description of events occurring on waiting list
Donor scores (DRI, ELTR) (Donor population)	5 years
severity of disease (Candidate population)	5 years
comorbidities (Candidate population)	5 years
time on waiting list (Candidate population)	5 years
percentages of drop-outs for improvement (Candidate population)	5 years