Critical Illness Clinical Trial
Official title:
Canada-DONATE: 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.
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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