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

Study Overview
=================
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.

Official Title
-----------------
Optimizing Donor-recipient Matching to Improve Survival After Registration on the Waiting List for Liver Transplantation: the OPTIMATCH LT Study

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort R1 and Cohort T1<br>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<br>Cohort R2 (patients on the waiting list in 2014) and Cohort T2 (transplanted patients in 2014) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| frequency of ECD criteria (Donor population) |  | 5 years | 
| mean age of donors (Donor population) |  | 5 years | 
| graft failure (Donor population) |  | 5 years | 
| grafts with correct primary function (Donor population) |  | 5 years | 
| epidemiological characteristics (Candidate population) |  | 5 years | 
| indication for transplantation (Candidate population) |  | 5 years | 
| severity of disease (Candidate population) |  | 5 years | 
| comorbidities (Candidate population) |  | 5 years | 
| time on waiting list (Candidate population) |  | 5 years | 
| Proportion of early deaths after transplantation (Candidate population) |  | 5 years | 
| drop-outs for worsening (Candidate population) | Description of events occurring on waiting list | 5 years | 
| deaths on the waiting list (Candidate population) |  | 5 years | 
| median time of occurrence (Candidate population) | Description of events occurring on waiting list | 5 years | 
| number of drop-outs for improvement (Candidate population) |  | 5 years | 
| percentages of drop-outs for improvement (Candidate population) |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplantation, Allocation process, Extended-criteria donors, Survival