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NCT Number: NCT03114436

National Observational Study of Clinical Practices in Deceased Organ Donation

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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About this study

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:

  • Establish specialized organ donation research teams at participating ICUs.
  • 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.
  • Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
  • 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.
  • Produce specific knowledge translation tools that will serve in the future as clinical tools to enhance ICU care and research tools to facilitate RCTs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observational Data Collection

Other

All aspects of deceased donor care in the ICU.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Official study title

Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation

Acronym: CanadaDONATE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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