Liver TransplantationOPTIMATCH-LTNCT03371264
Data Collection Study From Donors and Recipients to Optimize Donor-recipient Matching in Liver Transplantation
An observational study of Liver Transplantation, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Population of proposed donors and the population of patients registered on the national waiting list from 2009 to 2014 (Agence de Biomédecine)
Who may be able to join
- 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.
Who cannot join
- Pediatric recipients
- Pediatric donors
About this study
Official title: Optimizing Donor-recipient Matching to Improve Survival After Registration on the Waiting List for Liver Transplantation: the OPTIMATCH LT Study
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.
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, Allocation process, Extended-criteria donors, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival analysis
In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models
Measured: 5 years
Multi-state models
In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models
Measured: 5 years
Decision tree analysis
In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models
Measured: 5 years
Secondary outcomes (20)
Number of each criterion of ECD (Donor population)
Measured: 5 years
Percentage of each criterion of ECD (Donor population)
Measured: 5 years
Donor scores (DRI, ELTR) (Donor population)
Measured: 5 years
mean score (Donor population)
Measured: 5 years
number of ECD criteria (Donor population)
Measured: 5 years
frequency of ECD criteria (Donor population)
Measured: 5 years
mean age of donors (Donor population)
Measured: 5 years
graft failure (Donor population)
Measured: 5 years
grafts with correct primary function (Donor population)
Measured: 5 years
epidemiological characteristics (Candidate population)
Measured: 5 years
indication for transplantation (Candidate population)
Measured: 5 years
severity of disease (Candidate population)
Measured: 5 years
comorbidities (Candidate population)
Measured: 5 years
time on waiting list (Candidate population)
Measured: 5 years
Proportion of early deaths after transplantation (Candidate population)
Measured: 5 years
drop-outs for worsening (Candidate population)
Description of events occurring on waiting list
Measured: 5 years
deaths on the waiting list (Candidate population)
Measured: 5 years
median time of occurrence (Candidate population)
Description of events occurring on waiting list
Measured: 5 years
number of drop-outs for improvement (Candidate population)
Measured: 5 years
percentages of drop-outs for improvement (Candidate population)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start1 Jan 2015
- Primary completion1 Jan 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Sponsor
- Investigators
- Cyrille Feray, MD/PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371264
- Sponsor's protocol ID
- P13639
- Acronym
- OPTIMATCH-LT
- Status last verified
- Dec 2020
- First submitted
- 17 Nov 2017
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Donor-recipient Matching to Improve Survival After Registration on the Waiting List for Liver Transplantation: the OPTIMATCH LT Study
- ClinicalTrials.gov ID
- NCT03371264
- Acronym / sponsor ID
- OPTIMATCH-LT / P13639
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, Allocation process, Extended-criteria donors, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Population of proposed donors and the population of patients registered on the national waiting list from 2009 to 2014 (Agence de Biomédecine)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Pediatric recipients
- Pediatric donors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
20 secondary outcomes
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
deaths on the waiting list (Candidate population)
Time frame: 5 years
median time of occurrence (Candidate population)
Time frame: 5 years
number of drop-outs for improvement (Candidate population)
Time frame: 5 years
percentages of drop-outs for improvement (Candidate population)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrille Feray, MD/PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival analysis (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.