Data Collection Study From Donors and Recipients to Optimize Donor-recipient Matching in Liver Transplantation (OPTIMATCH-LT)
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ClinicalTrials.gov Identifier: NCT03371264 |
Recruitment Status :
Completed
First Posted : December 13, 2017
Last Update Posted : December 14, 2020
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Agence de La Biomédecine
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
Tracking Information | |||||
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First Submitted Date | November 17, 2017 | ||||
First Posted Date | December 13, 2017 | ||||
Last Update Posted Date | December 14, 2020 | ||||
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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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 |
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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 |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
9000 | ||||
Original Actual Enrollment | Same as current | ||||
Actual 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
Study Sponsor | Assistance Publique - Hôpitaux de Paris | ||||
Collaborators | Agence de La Biomédecine | ||||
Investigators |
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PRS Account | Assistance Publique - Hôpitaux de Paris | ||||
Verification Date | December 2020 |