Critical Illness, Deceased Organ Donation, Transplantation
Conditions
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.
Interventions
All aspects of deceased donor care in the ICU.
Sponsors
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
McMaster University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Canada
Outcome results
None listed