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Canada-DONATE study protocol: a prospective national observational study of the medical management of deceased organ donors
  1. Frederick D’Aragon1,2,
  2. Sonny Dhanani3,
  3. Francois Lamontagne2,4,
  4. Deborah J Cook5,6,
  5. Karen Burns7,8,
  6. Aemal Akhtar6,
  7. Michaël Chassé9,
  8. Anne-Julie Frenette10,11,
  9. Sean Keenan12,
  10. Jean-Francois Lize9,
  11. Demetrios J Kutsogiannis13,
  12. Andreas Kramer14,
  13. Lori E Hand6,
  14. Erika Arseneau6,
  15. Marie-Helene Masse2,
  16. Christine Ribic5,15,
  17. Ian Ball16,17,
  18. Andrew Baker7,18,
  19. Gordon Boyd19,20,
  20. Bram Rochwerg5,6,
  21. Andrew Healey5,
  22. Steven Hanna6,
  23. Gordon H Guyatt5,6,
  24. Maureen O Meade5,6
  25. for the Canadian Critical Care Trials Group and the Canadian National Transplant Research Program
  1. 1 Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada
  2. 2 Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
  3. 3 Division of Critical Care, Department of Pediatrics, Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada
  4. 4 Department of Medicine, Universite de Sherbrooke, Sherbrooke, Ontario, Canada
  5. 5 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  6. 6 Department of Health Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  7. 7 Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada
  8. 8 Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Ontario, Canada
  9. 9 Department of Medicine (Critical Care), Centre Hospitalier de l’Universite de Montreal, Montreal, Quebec, Canada
  10. 10 Pharmacy Faculty, Universite de Montreal, Montreal, Quebec, Canada
  11. 11 Hopital Sacre-Coeur de Montreal, Montreal, Quebec, Canada
  12. 12 Department of Critical Care, Royal Columbian Hospital, New Westminster, British Columbia, Canada
  13. 13 Department of Critical Care Medicine, University of Alberta, Edmonton, Alberta, Canada
  14. 14 Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada
  15. 15 Division of Nephrology, St. Joseph’s Healthcare, Hamilton, Ontario, Canada
  16. 16 Department of Medicine, Western University, London, Ontario, Canada
  17. 17 Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
  18. 18 Departments of Anaesthesia and Surgery, University of Toronto, Toronto, Ontario, Canada
  19. 19 Department of Medicine (Neurology), Queen’s University, Kingston, Ontario, Canada
  20. 20 Department of Critical Care Medicine, Queen’s University, Kingston, Ontario, Canada
  1. Correspondence to Dr Frederick D’Aragon; Frederick.DAragon{at}USherbrooke.ca

Abstract

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.

  • organ donation
  • transplant medicine
  • brain death

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors All authors made material contributions to this manuscript according to the rules of authorship of ICMJE. Specifically, the contributions of each author are as follows: FD, SD, DJC, A-JF, GHG, FL, MOM: conception of the design, draft and revised the manuscript, and approved the final version to be published; AA, EA, AB, IB, GB, KB, MC, LEH, SH, AH, SK, AK, DJK, J-FL, M-HM, CR, BR: reviewed the design, draft and revised the manuscript, and approved the final version to be published.

  • Funding This work is supported by: the Hamilton Health Sciences RFA Strategic Initiatives Program; the Hamilton Health Sciences New Investigator Fund; a Canadian Blood Services Kenneth J. Fyke award; the Canadian Institutes for Health Research (FRN94829) and the Fond de Recherches de la Fondation des Anesthesiologistes du Quebec.

  • Competing interests None declared.

  • Ethics approval Hamilton Integrated Research Ethics Board.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Collaborators Canadian Critical Care Trials Group, the Canadian National Transplant Research Program, Canadian Blood Services, British Columbia Transplant, the Northern Alberta HOPE Program, the Southern Alberta Organ Donation Program, the Trillium Gift of Life Network of Ontario and Transplant Quebec.

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