National Observational Study of Clinical Practices in Deceased Organ Donation

Critical Illness Clinical Trial

— CanadaDONATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114436
• Other study ID #: Canada-DONATE 0780-PIA
• Status: Completed
• Start date: August 31, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: May 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Death
• Deceased Organ Donation
• Transplantation

Intervention

Other:
• Observational Data Collection
All aspects of deceased donor care in the ICU.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Science - Juravinski Hospital	Hamilton	Ontario
Canada	Hamilton Health Sciences - Hamilton General Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	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	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 hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal	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	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital - General Hospital	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Québec - Université Laval	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Royal Jubilee Hospital	Victoria	British Columbia
Canada	Victoria General Hospital	Victoria	British Columbia

Sponsors (10)

Lead Sponsor	Collaborator
McMaster University	BC Transplant, Canadian Blood Services, Canadian Critical Care Trials Group, Canadian National Transplant Research Program, Hamilton Health Sciences Corporation, Human Organ Procurement and Exchange, Southern Alberta Organ Donation Program, Transplant Quebec, Trillium Gift of Life Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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.

External Links

•   Canada-DONATE Research Progam Website