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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114436
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Maureen O. Meade, McMaster University

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
Deceased Organ Donation Critical Illness Transplantation 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.

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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 : August 31, 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

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.




Primary Outcome Measures :
  1. Adherence to national guidelines for deceased donor care [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients for whom consent for deceased organ donation has been obtained.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114436


Locations
Show Show 29 study locations
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
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Principal Investigator: Frederick D'Aragon, MD, MSc Université de Sherbrooke
Study Director: Maureen O Meade, MD, MSc McMaster University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maureen O. Meade, Research Program Director, McMaster University
ClinicalTrials.gov Identifier: NCT03114436    
Other Study ID Numbers: Canada-DONATE 0780-PIA
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Death
Disease Attributes
Pathologic Processes