National Observational Study of Clinical Practices in Deceased Organ Donation

Completed

• Conditions: Deceased Organ Donation; Transplantation; Critical Illness
• Interventions: Other: Observational Data Collection

• Registration Number: NCT03114436
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-31
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 622

Inclusion Criteria

• Admitted into a critical care area (ICU, CCU, ER)
• Consent has been obtained for Organ Donation

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Exclusion Criteria

• Admitted into a paediatric critical care area (NICU, PICU)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consented deceased organ donors	Observational Data Collection	Includes neurological determination of death (DND) and by circulatory determination of death (DCD).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (29)

The Ottawa Hospital - Civic Campus; 🇨🇦 Ottawa, Ontario, Canada

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal; 🇨🇦 Montreal, Quebec, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Hamilton Health Sciences - Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

Hamilton Health Science - Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre - Victoria Hospital; 🇨🇦 London, Ontario, Canada

Trillium Health Partners - Trillium Health Centre; 🇨🇦 Mississauga, Ontario, Canada

The Ottawa Hospital - General Hospital; 🇨🇦 Ottawa, Ontario, Canada

Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame; 🇨🇦 Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal - Hôpital Saint-Luc; 🇨🇦 Montreal, Quebec, Canada

Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Général de Montreal; 🇨🇦 Montreal, Quebec, Canada

Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Royal Victoria; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec - Université Laval; 🇨🇦 Quebec, Canada

Victoria General Hospital; 🇨🇦 Victoria, British Columbia, Canada

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada