Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371264
Recruitment Status : Active, not recruiting
First Posted : December 13, 2017
Last Update Posted : August 6, 2019
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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