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Completed

NCT Number: NCT03371264

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

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Number of each criterion of ECD (Donor population)

    Time frame: 5 years

  2. Percentage of each criterion of ECD (Donor population)

    Time frame: 5 years

  3. Donor scores (DRI, ELTR) (Donor population)

    Time frame: 5 years

  4. mean score (Donor population)

    Time frame: 5 years

  5. number of ECD criteria (Donor population)

    Time frame: 5 years

  6. frequency of ECD criteria (Donor population)

    Time frame: 5 years

  7. mean age of donors (Donor population)

    Time frame: 5 years

  8. graft failure (Donor population)

    Time frame: 5 years

  9. grafts with correct primary function (Donor population)

    Time frame: 5 years

  10. epidemiological characteristics (Candidate population)

    Time frame: 5 years

  11. indication for transplantation (Candidate population)

    Time frame: 5 years

  12. severity of disease (Candidate population)

    Time frame: 5 years

  13. comorbidities (Candidate population)

    Time frame: 5 years

  14. time on waiting list (Candidate population)

    Time frame: 5 years

  15. Proportion of early deaths after transplantation (Candidate population)

    Time frame: 5 years

  16. drop-outs for worsening (Candidate population)

    Time frame: 5 years

    Description of events occurring on waiting list

  17. deaths on the waiting list (Candidate population)

    Time frame: 5 years

  18. median time of occurrence (Candidate population)

    Time frame: 5 years

    Description of events occurring on waiting list

  19. number of drop-outs for improvement (Candidate population)

    Time frame: 5 years

  20. percentages of drop-outs for improvement (Candidate population)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Agence de La Biomédecine

Registry information

Official study title

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

Acronym: OPTIMATCH-LT

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Dec 13, 2017
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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