National Observational Study of Clinical Practices in Deceased Organ Donation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transplantation, Deceased Organ Donation, Critical Illness

Intervention / Treatment
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* Other: Observational Data Collection


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consented deceased organ donors<br>Includes neurological determination of death (DND) and by circulatory determination of death (DCD). | Other: Observational Data Collection<br>* All aspects of deceased donor care in the ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Duration of deceased donor care in the ICU (1-5 days per donor). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ donation | This refers to the conversion of a consented organ donor to an actual organ donor. | 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. | Transplantation may occur from 1-5 days from the time of consent. |