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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

Tracking Information
First Submitted Date April 10, 2017
First Posted Date April 14, 2017
Last Update Posted Date May 23, 2019
Actual Study Start Date August 31, 2016
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 11, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Observational Study of Clinical Practices in Deceased Organ Donation
Official Title Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients for whom consent for deceased organ donation has been obtained.
Condition
  • Deceased Organ Donation
  • Critical Illness
  • Transplantation
Intervention Other: Observational Data Collection
All aspects of deceased donor care in the ICU.
Study Groups/Cohorts Consented deceased organ donors
Includes neurological determination of death (DND) and by circulatory determination of death (DCD).
Intervention: Other: Observational Data Collection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2019)
622
Original Estimated Enrollment
 (submitted: April 11, 2017)
450
Actual Study Completion Date July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03114436
Other Study ID Numbers Canada-DONATE 0780-PIA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Maureen O. Meade, McMaster University
Study Sponsor McMaster University
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
Investigators
Principal Investigator: Frederick D'Aragon, MD, MSc Université de Sherbrooke
Study Director: Maureen O Meade, MD, MSc McMaster University
PRS Account McMaster University
Verification Date May 2019