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

Liver Transplantation Clinical Trial

— OPTIMATCH-LT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371264
• Other study ID #: P13639
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 1, 2020

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Agence de La Biomédecine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival analysis	In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models	5 years
Primary	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
Primary	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	Number of each criterion of ECD (Donor population)		5 years
Secondary	Percentage of each criterion of ECD (Donor population)		5 years
Secondary	Donor scores (DRI, ELTR) (Donor population)		5 years
Secondary	mean score (Donor population)		5 years
Secondary	number of ECD criteria (Donor population)		5 years
Secondary	frequency of ECD criteria (Donor population)		5 years
Secondary	mean age of donors (Donor population)		5 years
Secondary	graft failure (Donor population)		5 years
Secondary	grafts with correct primary function (Donor population)		5 years
Secondary	epidemiological characteristics (Candidate population)		5 years
Secondary	indication for transplantation (Candidate population)		5 years
Secondary	severity of disease (Candidate population)		5 years
Secondary	comorbidities (Candidate population)		5 years
Secondary	time on waiting list (Candidate population)		5 years
Secondary	Proportion of early deaths after transplantation (Candidate population)		5 years
Secondary	drop-outs for worsening (Candidate population)	Description of events occurring on waiting list	5 years
Secondary	deaths on the waiting list (Candidate population)		5 years
Secondary	median time of occurrence (Candidate population)	Description of events occurring on waiting list	5 years
Secondary	number of drop-outs for improvement (Candidate population)		5 years
Secondary	percentages of drop-outs for improvement (Candidate population)		5 years