Clinical trial NCT03371264: Data Collection Study From Donors and Recipients to Optimize Donor-recipient Matching in Liver Transplantation
Official title: Optimizing Donor-recipient Matching to Improve Survival After Registration on the Waiting List for Liver Transplantation: the OPTIMATCH LT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: Liver transplantation
Allocation process
Extended-criteria donors
Survival
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
First posted: 2017-12-13
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival analysis
timeFrame: 5 years
measure: Multi-state models
timeFrame: 5 years
measure: Decision tree analysis
timeFrame: 5 years
Secondary outcomes:
measure: Number of each criterion of ECD (Donor population)
timeFrame: 5 years
measure: Percentage of each criterion of ECD (Donor population)
timeFrame: 5 years
measure: Donor scores (DRI, ELTR) (Donor population)
timeFrame: 5 years
measure: mean score (Donor population)
timeFrame: 5 years
measure: number of ECD criteria (Donor population)
timeFrame: 5 years
measure: frequency of ECD criteria (Donor population)
timeFrame: 5 years
measure: mean age of donors (Donor population)
timeFrame: 5 years
measure: graft failure (Donor population)
timeFrame: 5 years
measure: grafts with correct primary function (Donor population)
timeFrame: 5 years
measure: epidemiological characteristics (Candidate population)
timeFrame: 5 years
measure: indication for transplantation (Candidate population)
timeFrame: 5 years
measure: severity of disease (Candidate population)
timeFrame: 5 years
measure: comorbidities (Candidate population)
timeFrame: 5 years
measure: time on waiting list (Candidate population)
timeFrame: 5 years
measure: Proportion of early deaths after transplantation (Candidate population)
timeFrame: 5 years
measure: drop-outs for worsening (Candidate population)
timeFrame: 5 years
measure: deaths on the waiting list (Candidate population)
timeFrame: 5 years
measure: median time of occurrence (Candidate population)
timeFrame: 5 years
measure: number of drop-outs for improvement (Candidate population)
timeFrame: 5 years
measure: percentages of drop-outs for improvement (Candidate population)
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Cyrille Feray, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: