National Observational Study of Clinical Practices in Deceased Organ Donation

NCT03114436 | Completed

• 1 other identifier: Canada-DONATE 0780-PIA
• Study Type: observational
• Target: 622
• Locations: 1 country
• Sites: 29

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.

Conditions

Deceased Organ Donation; Critical Illness; Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Organ donation

  Duration of deceased donor care in the ICU (1-5 days per donor).

• Organ transplantation

  Transplantation may occur from 1-5 days from the time of consent.

Study Arms (1)

Consented deceased organ donors

Includes neurological determination of death (DND) and by circulatory determination of death (DCD).

Other: Observational Data Collection

Interventions

Observational Data Collection OTHER

All aspects of deceased donor care in the ICU.

Consented deceased organ donors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Critical Care Trials Group: collaborator
• Canadian National Transplant Research Program: collaborator
• Transplant Quebec: collaborator
• Trillium Gift of Life Network: collaborator
• BC Transplant: collaborator
• Southern Alberta Organ Donation Program: collaborator
• Human Organ Procurement and Exchange: collaborator
• Canadian Blood Services: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (29)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

Location

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Hamilton Health Science - Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Trillium Health Partners - Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1H 8G7, Canada

Location

The Ottawa Hospital - General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Centre hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Centre hospitalier de l'Université de Montréal - Hôpital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Général de Montreal

Montreal, Quebec, H3G 1A4, Canada

Location

Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Royal Victoria

Montreal, Quebec, H4A 3J1, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Universitaire de Québec - Université Laval

Québec, G1V 4G2, Canada

Location

Related Publications (2)

• 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.

  PMID: 32385825 DERIVED

• 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.

  PMID: 28963316 DERIVED

Related Links

• Canada-DONATE Research Progam Website

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederick D'Aragon, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Maureen O Meade, MD, MSc

  McMaster University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Program Director

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 14, 2017
• Study Start: August 31, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

CA (29)