National Observational Study of Clinical Practices in Deceased Organ Donation (CanadaDONATE)

Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation

This is a 1-year national prospective cohort study that observes the medical management of consented deceased organ donors at hospitals across Canada with a high volume of deceased donation.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Transplantation; Deceased Organ Donation
• Intervention / Treatment: Other: Observational Data Collection

Detailed Description

This prospective cohort study enrols consecutive adult deceased organ donors with a waiver of research consent and collects various data related to deceased donor care in the ICU from the time of consent for donation to the time of organ recovery. Clinical data includes donor characteristics, type of donation (after neurological death or cardiocirculatory death), resuscitation methods, cardiopulmonary monitoring techniques, medications, blood work, mechanical ventilation, diagnostic imaging, complications, and methods of death declaration. Various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery.

The Canada-DONATE study is designed to develop a national platform for future clinical trials in deceased donor care. The main objectives include:

1. Establish specialized organ donation research teams at participating ICUs.
2. Observe, record, and describe ICU practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future RCTs.
3. Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
4. Investigate the comparative effectiveness of various ICU interventions in deceased donor care to improve the conversion of consented donors to actual donors and to improve the number of transplants per donor.
5. Produce specific knowledge translation tools that will serve in the future as clinical tools to enhance ICU care and research tools to facilitate RCTs.

• Study Type: Observational
• Enrollment (Actual): 622

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Centre Hospitalier Universitaire de Québec - Université Laval
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Royal Columbian Hospital
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Victoria, British Columbia, Canada, V8R 1J8
      • Royal Jubilee Hospital
    • Victoria, British Columbia, Canada, V8Z 6R5
      • Victoria General Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences - Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8V 1C3
      • Hamilton Health Science - Juravinski Hospital
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre - Victoria Hospital
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Partners - Trillium Health Centre
    • Ottawa, Ontario, Canada, K1H 8G7
      • The Ottawa Hospital - Civic Campus
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital - General Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St Michael's Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • University Health Network - Toronto Western Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montreal
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
    • Montreal, Quebec, Canada, H2W 1T8
      • Centre hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal
    • Montreal, Quebec, Canada, H2X 3J4
      • Centre hospitalier de l'Université de Montréal - Hôpital Saint-Luc
    • Montreal, Quebec, Canada, H3G 1A4
      • Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Général de Montreal
    • Montreal, Quebec, Canada, H4A 3J1
      • Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Royal Victoria
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients for whom consent for deceased organ donation has been obtained.

Description

Inclusion Criteria:

• Admitted into a critical care area (ICU, CCU, ER)
• Consent has been obtained for Organ Donation

Exclusion Criteria:

• Admitted into a paediatric critical care area (NICU, PICU)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consented deceased organ donors; Includes neurological determination of death (DND) and by circulatory determination of death (DCD).	Other: Observational Data Collection; All aspects of deceased donor care in the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to national guidelines for deceased donor care	For each donor, we will measure adherence to multiple recommendations from national guidelines for the management of deceased organ donors.	Duration of deceased donor care in the ICU (1-5 days per donor).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ donation	This refers to the conversion of a consented organ donor to an actual organ donor.	Duration of deceased donor care in the ICU (1-5 days per donor).
Organ transplantation	Deceased organ donors can provide up to 8 organ donations each. We will measure the number of transplants that proceed from each consented donor.	Transplantation may occur from 1-5 days from the time of consent.

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; Canadian Blood Services; Canadian National Transplant Research Program; Canadian Critical Care Trials Group; Transplant Quebec; Trillium Gift of Life Network; BC Transplant; Southern Alberta Organ Donation Program; Human Organ Procurement and Exchange
• Investigators: Principal Investigator: Frederick D'Aragon, MD, MSc, Université de Sherbrooke; Study Director: Maureen O Meade, MD, MSc, McMaster University

Publications and helpful links

General Publications

• D'Aragon F, Lamontagne F, Cook D, Dhanani S, Keenan S, Chasse M, English S, Burns KEA, Frenette AJ, Ball I, Boyd JG, Masse MH, Breau R, Akhtar A, Kramer A, Rochwerg B, Lauzier F, Kutsogiannis DJ, Ibrahim Q, Hand L, Zhou Q, Meade MO; Canadian Critical Care Trials Group and the Canadian Donation and Transplant Research Program. Variability in deceased donor care in Canada: a report of the Canada-DONATE cohort study. Can J Anaesth. 2020 Aug;67(8):992-1004. doi: 10.1007/s12630-020-01692-7. Epub 2020 May 8.
• D'Aragon F, Dhanani S, Lamontagne F, Cook DJ, Burns K, Akhtar A, Chasse M, Frenette AJ, Keenan S, Lize JF, Kutsogiannis DJ, Kramer A, Hand LE, Arseneau E, Masse MH, Ribic C, Ball I, Baker A, Boyd G, Rochwerg B, Healey A, Hanna S, Guyatt GH, Meade MO; Canadian Critical Care Trials Group and the Canadian National Transplant Research Program. Canada-DONATE study protocol: a prospective national observational study of the medical management of deceased organ donors. BMJ Open. 2017 Sep 28;7(9):e018858. doi: 10.1136/bmjopen-2017-018858.

Helpful Links

• Canada-DONATE Research Progam Website

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Death; Critical Illness
• Other Study ID Numbers: Canada-DONATE 0780-PIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No