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CanadaDONATE: National Observational Study of Clinical Practices in Deceased Organ Donation

Sponsor
McMaster University (Other)
Overall Status
Completed
CT.gov ID
NCT03114436
Collaborator
Canadian Critical Care Trials Group (Other), Canadian National Transplant Research Program (Other), Transplant Quebec (Other), Trillium Gift of Life Network (Other), BC Transplant (Other), Southern Alberta Organ Donation Program (Other), Human Organ Procurement and Exchange (Other), Canadian Blood Services (Other), Hamilton Health Sciences Corporation (Other)
622
Enrollment
29
Locations
23
Actual Duration (Months)
21.4
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
622 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation
Actual Study Start Date :
Aug 31, 2016
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Jul 31, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Adherence to national guidelines for deceased donor care [Duration of deceased donor care in the ICU (1-5 days per donor).]

    For each donor, we will measure adherence to multiple recommendations from national guidelines for the management of deceased organ donors.

Secondary Outcome Measures

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

    This refers to the conversion of a consented organ donor to an actual organ donor.

  2. Organ transplantation [Transplantation may occur from 1-5 days from the time of consent.]

    Deceased organ donors can provide up to 8 organ donations each. We will measure the number of transplants that proceed from each consented donor.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Frederick D'Aragon, MD, MSc, Université de Sherbrooke
  • Study Director: Maureen O Meade, MD, MSc, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Maureen O. Meade, Research Program Director, McMaster University
ClinicalTrials.gov Identifier:
NCT03114436
Other Study ID Numbers:
  • Canada-DONATE 0780-PIA
First Posted:
Apr 14, 2017
Last Update Posted:
May 23, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Critical Illness
Death

Study Results

No Results Posted as of May 23, 2019