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

• ClinicalTrials.gov Identifier: NCT03371264
• Recruitment Status: Active, not recruiting
• First Posted: December 13, 2017
• Last Update Posted: August 6, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Agence de La Biomédecine
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: November 17, 2017
• First Posted Date: December 13, 2017
• Last Update Posted Date: August 6, 2019
• Actual Study Start Date: January 1, 2015
• Actual Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2017)

• Survival analysis [ Time Frame: 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 [ Time Frame: 5 years ]
  In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models
• Decision tree analysis [ Time Frame: 5 years ]
  In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 7, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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)
• Condition: Liver Transplantation
• Intervention: Not Provided

Study Groups/Cohorts

• 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)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 7, 2017): 9000
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2020
• Actual Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03371264
• Other Study ID Numbers: P13639
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Agence de La Biomédecine

Investigators

• Principal Investigator: Cyrille Feray, MD/PhD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: August 2019