Deceased Organ DonationCanadaDONATENCT03114436
National Observational Study of Clinical Practices in Deceased Organ Donation
An observational study of Deceased Organ Donation and Critical Illness, run by McMaster University at 29 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deceased Organ Donation, Critical Illness, Transplantation
- What is being tested?
- Observational Data Collection
- How many people
- 622 participants
- Where
- 29 sitesCanada
- Study dates
- 31 Aug 2016to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients for whom consent for deceased organ donation has been obtained.
Who may be able to join
- Admitted into a critical care area (ICU, CCU, ER)
- Consent has been obtained for Organ Donation
Who cannot join
- Admitted into a paediatric critical care area (NICU, PICU)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Canada29 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Hamilton Health Science - Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Trillium Health Partners - Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
Centre hospitalier de l'Université de Montréal - Hôtel-Dieu de Montréal
Montreal, Quebec, H2W 1T8
Centre hospitalier de l'Université de Montréal - Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4
Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Général de Montreal
Montreal, Quebec, H3G 1A4
Centre Universitaire de Santé McGill/McGill University Health Centre - Hôpital Royal Victoria
Montreal, Quebec, H4A 3J1
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1H 8G7
The Ottawa Hospital - General Hospital
Ottawa, Ontario, K1H 8L6
Centre Hospitalier Universitaire de Québec - Université Laval
Québec, G1V 4G2
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
About this study
Official title: Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation
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.
Read the 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:
- 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.
- Conditions
- Deceased Organ Donation, Critical Illness, Transplantation
- Being tested
- Observational Data Collection
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Data CollectionOther
All aspects of deceased donor care in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Consented deceased organ donors | Includes neurological determination of death (DND) and by circulatory determination of death (DCD). Receives: Other: Observational Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of deceased donor care in the ICU (1-5 days per donor).
Secondary outcomes (2)
Organ donation
This refers to the conversion of a consented organ donor to an actual organ donor.
Measured: 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.
Measured: Transplantation may occur from 1-5 days from the time of consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start31 Aug 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deceased Organ DonationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Canadian National Transplant Research Program, Transplant Quebec, Trillium Gift of Life Network, BC Transplant, Southern Alberta Organ Donation Program, Human Organ Procurement and Exchange, Canadian Blood Services, Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Maureen O. Meade, McMaster University
- Investigators
- Frederick D'Aragon, MD, MSc, Principal investigator, Université de SherbrookeMaureen O Meade, MD, MSc, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114436
- Sponsor's protocol ID
- Canada-DONATE 0780-PIA
- Acronym
- CanadaDONATE
- Status last verified
- May 2019
- First submitted
- 10 Apr 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32385825D'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.
PubMed 28963316
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation
- ClinicalTrials.gov ID
- NCT03114436
- Acronym / sponsor ID
- CanadaDONATE / Canada-DONATE 0780-PIA
- Conditions
- Deceased Organ Donation, Critical Illness, Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Canadian National Transplant Research Program, Transplant Quebec, Trillium Gift of Life Network, BC Transplant, Southern Alberta Organ Donation Program, Human Organ Procurement and Exchange, Canadian Blood Services, Hamilton Health Sciences Corporation
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consented deceased organ donors | – | Other: Observational Data CollectionIncludes neurological determination of death (DND) and by circulatory determination of death (DCD). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients for whom consent for deceased organ donation has been obtained.
Key inclusion criteria (2 listed)
- Admitted into a critical care area (ICU, CCU, ER)
- Consent has been obtained for Organ Donation
Key exclusion criteria (1 listed)
- Admitted into a paediatric critical care area (NICU, PICU)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Data CollectionAll aspects of deceased donor care in the ICU. | Other | Consented deceased organ donors |
Primary outcome
Adherence to national guidelines for deceased donor care
Time frame: 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.
2 secondary outcomes
Organ donation
Time frame: Duration of deceased donor care in the ICU (1-5 days per donor).
Organ transplantation
Time frame: Transplantation may occur from 1-5 days from the time of consent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Derived from this study: PubMed 32385825D'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.
- Derived from this study: PubMed 28963316D'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.
- Canada-DONATE Research Progam WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick D'Aragon, MD, MSc principal investigator
Université de Sherbrooke
Maureen O Meade, MD, MSc study director
McMaster University
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deceased Organ Donation and Critical Illness, run by McMaster University at 29 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to national guidelines for deceased donor care (time frame: Duration of deceased donor care in the ICU (1-5 days per donor).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.