Clinical trial NCT03114436: National Observational Study of Clinical Practices in Deceased Organ Donation
Official title: Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deceased Organ Donation
Critical Illness
Transplantation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Critical Care Trials Group
name: Canadian National Transplant Research Program
name: Transplant Quebec
name: Trillium Gift of Life Network
name: BC Transplant
name: Southern Alberta Organ Donation Program
name: Human Organ Procurement and Exchange
name: Canadian Blood Services
name: Hamilton Health Sciences Corporation
First posted: 2017-04-14
Enrollment: 622
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients for whom consent for deceased organ donation has been obtained.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adherence to national guidelines for deceased donor care
timeFrame: Duration of deceased donor care in the ICU (1-5 days per donor).
Secondary outcomes:
measure: Organ donation
timeFrame: Duration of deceased donor care in the ICU (1-5 days per donor).
measure: Organ transplantation
timeFrame: Transplantation may occur from 1-5 days from the time of consent.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Science - Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Trillium Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal - Hôpital Saint-Luc
state: Quebec
city: Montreal
country: Canada
facility: Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Général de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Royal Victoria
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Québec - Université Laval
Study officials:
affiliation: Université de Sherbrooke
name: Frederick D'Aragon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Maureen O Meade, MD, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.