An observational study in Deceased Organ Donation, Critical Illness and Transplantation, sponsored by McMaster University. Completed at 29 sites in Canada. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by McMaster University · Observational
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:
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 622 is above the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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All patients for whom consent for deceased organ donation has been obtained.
Exclusion Criteria:
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.
Adherence to national guidelines for deceased donor care
For each donor, we will measure adherence to multiple recommendations from national guidelines for the management of deceased organ donors.
Time frame: Duration of deceased donor care in the ICU (1-5 days per donor).
Organ donation
This refers to the conversion of a consented organ donor to an actual organ donor.
Time frame: Duration of deceased donor care in the ICU (1-5 days per donor).
Organ transplantation
Deceased organ donors can provide up to 8 organ donations each. We will measure the number of transplants that proceed from each consented donor.
Time frame: Transplantation may occur from 1-5 days from the time of consent.
Plan to share: Undecided
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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