National Observational Study of Clinical Practices in Deceased Organ Donation

NCT ID: NCT03114436

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

622 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-07-31

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:

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.

Conditions

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Deceased Organ Donation Critical Illness Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consented deceased organ donors

Includes neurological determination of death (DND) and by circulatory determination of death (DCD).

Observational Data Collection

Intervention Type OTHER

All aspects of deceased donor care in the ICU.

Interventions

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Observational Data Collection

All aspects of deceased donor care in the ICU.

Intervention Type OTHER

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Critical Care Trials Group

OTHER

Sponsor Role collaborator

Canadian National Transplant Research Program

OTHER

Sponsor Role collaborator

Transplant Quebec

UNKNOWN

Sponsor Role collaborator

Trillium Gift of Life Network

UNKNOWN

Sponsor Role collaborator

BC Transplant

UNKNOWN

Sponsor Role collaborator

Southern Alberta Organ Donation Program

UNKNOWN

Sponsor Role collaborator

Human Organ Procurement and Exchange

UNKNOWN

Sponsor Role collaborator

Canadian Blood Services

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Maureen O. Meade

Research Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederick D'Aragon, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Maureen O Meade, MD, MSc

Role: STUDY_DIRECTOR

McMaster University

Locations

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Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Site Status

Victoria General Hospital

Victoria, British Columbia, Canada

Site Status

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Hamilton Health Science - Juravinski Hospital

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Site Status

Trillium Health Partners - Trillium Health Centre

Mississauga, Ontario, Canada

Site Status

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Site Status

The Ottawa Hospital - General Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Site Status

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame

Montreal, Quebec, Canada

Site Status

Centre hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal

Montreal, Quebec, Canada

Site Status

Centre hospitalier de l'Université de Montréal - Hôpital Saint-Luc

Montreal, Quebec, Canada

Site Status

Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Général de Montreal

Montreal, Quebec, Canada

Site Status

Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Royal Victoria

Montreal, Quebec, Canada

Site Status

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Québec - Université Laval

Québec, , Canada

Site Status

Countries

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Canada

References

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D'Aragon F, Lamontagne F, Cook D, Dhanani S, Keenan S, Chasse M, English S, Burns KEA, Frenette AJ, Ball I, Boyd JG, Masse MH, Breau R, Akhtar A, Kramer A, Rochwerg B, Lauzier F, Kutsogiannis DJ, Ibrahim Q, Hand L, Zhou Q, Meade MO; Canadian Critical Care Trials Group and the Canadian Donation and Transplant Research Program. Variability in deceased donor care in Canada: a report of the Canada-DONATE cohort study. Can J Anaesth. 2020 Aug;67(8):992-1004. doi: 10.1007/s12630-020-01692-7. Epub 2020 May 8.

Reference Type DERIVED
PMID: 32385825 (View on PubMed)

D'Aragon F, Dhanani S, Lamontagne F, Cook DJ, Burns K, Akhtar A, Chasse M, Frenette AJ, Keenan S, Lize JF, Kutsogiannis DJ, Kramer A, Hand LE, Arseneau E, Masse MH, Ribic C, Ball I, Baker A, Boyd G, Rochwerg B, Healey A, Hanna S, Guyatt GH, Meade MO; Canadian Critical Care Trials Group and the Canadian National Transplant Research Program. Canada-DONATE study protocol: a prospective national observational study of the medical management of deceased organ donors. BMJ Open. 2017 Sep 28;7(9):e018858. doi: 10.1136/bmjopen-2017-018858.

Reference Type DERIVED
PMID: 28963316 (View on PubMed)

Related Links

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http://donate.ccctg.ca

Canada-DONATE Research Progam Website

Other Identifiers

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Canada-DONATE 0780-PIA

Identifier Type: -

Identifier Source: org_study_id

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