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Canada-DONATE study protocol: a prospective national observational study of the medical management of deceased organ
Frederick D'Aragon1,2, Sonny Dhanani3, Francois Lamontagne2,4
1Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada.
Introduction:
Research on the management of deceased organ donors aims to improve the number and quality of transplants and recipient outcomes. In Canada, this research is challenged by regionalisation of donation services within provinces and the geographical, clinical and administrative separation of donation from transplantation services. This study aims to build a national platform for future clinical trials in donor management. Objectives are to engage collaborators at donation hospitals and organ donation organisations (ODOs) across Canada, describe current practices, evaluate the effectiveness of donation-specific interventions and assess the feasibility of future clinical trials.
Methods And Analysis:
This ongoing prospective observational study of the medical management of deceased organ donors will enrol more than 650 consented potential donors from adult intensive care units at 33 hospital sites across Canada, each participating for 12 months. ODOs ensure enrolment of consecutive eligible participants. Research staff record detailed data about participants, therapies, organ assessments, death declaration procedures and adverse clinical exposures from the time of donation consent to organ recovery. ODOs provide reasons that organs are declined, dates and places of transplantation, and recipient age and sex.Descriptive analyses will summarise current practices. Effectiveness analyses will examine donation-specific interventions with respect to the number of transplants, using multilevel regression models to account for clustering by donor, hospitals and ODOs. Feasibility analyses will focus on acceptance of the research consent model; participation of academic and community hospitals as well as ODOs; and accessibility of recipient data.
Ethics And Dissemination:
This study uses a waiver of research consent. Hospitals will receive reports on local practices benchmarked to (1) national practices and (2) national donor management guidelines. We will report findings to donation and transplant collaborators (ie, clinicians, researchers, ODOs) and publish in peer-reviewed journals.
Trial Registration Number:
NCT03114436.
Insights
This study establishes a national platform to improve deceased organ donor management in Canada. It assesses current practices and intervention effectiveness to enhance transplant numbers and outcomes.
Area of Science:
- Organ transplantation research
- Deceased organ donor management
- Clinical trial methodology
Background:
- Canadian organ donation faces challenges due to fragmented services.
- A national platform is needed for robust clinical trials in donor management.
- Current research aims to improve transplant numbers and recipient outcomes.
Purpose of the Study:
- To establish a national platform for deceased organ donor management clinical trials.
- To engage collaborators across Canadian donation hospitals and organ donation organizations (ODOs).
- To describe current donor management practices, evaluate interventions, and assess trial feasibility.
Main Methods:
- Prospective observational study enrolling over 650 consented deceased donors across 33 Canadian sites.
- Data collection on donor management, organ assessment, and transplantation outcomes.
- Multilevel regression models to analyze intervention effectiveness on transplant numbers.
Main Results:
- Descriptive analyses of current donor management practices are being conducted.
- Effectiveness of donation-specific interventions on transplant rates will be evaluated.
- Feasibility of the consent model, multi-site participation, and recipient data access is assessed.
Conclusions:
- The study aims to create a foundation for future clinical trials in deceased organ donor management.
- Findings will inform national donor management guidelines and improve transplant efficiency.
- This initiative seeks to optimize organ utilization and enhance patient outcomes through collaborative research.
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