Organ DonationNCT04661787
Donation Advisor Clinical Decision Support Tool Study
An observational study of Organ Donation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Every year, thousands of Canadians receive life-saving, cost-effective organ transplants, while thousands more still wait or die because not enough organs are available. Patients with non-recoverable illnesses, who are undergoing withdrawal of life sustaining measures, can donate their organs when they die by a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Organ Donation
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jan 2021to 19 Dec 2023
- 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: 60-80 organ donation patients 180-240 transplant recipients (anticipated average of 3 per donor patient) 30-40 health care professionals to participate in interviews (reviewing the Donation Advisor Tool Reports)
Who may be able to join
- for Organ Donation Patients: All patients eligible for DCD and whose substitute decision makers (SDMs) have been approached for consent by a Trillium Organ Tissue Donation Coordinator (OTDC).
- for Organ Transplant Recipient Patients - All patients at any of the Transplant Centres participating in this study who are transplant recipients of the organs from enrolled donor patients.
- for Health Care Professionals for Interviews to provide feedback on the Donation Advisor Tool - All physicians (donation and transplantation), bedside nurses and OTDCs who either have the potential to be involved in the care of study patients, or who been directly involved in the care of the study patients.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Donation Advisor, a Personalized Clinical Decision Support Tool for Improved Efficiency and Effectiveness of Deceased Organ Donation and Transplantation
Every year, thousands of Canadians receive life-saving, cost-effective organ transplants, while thousands more still wait or die because not enough organs are available. Patients with non-recoverable illnesses, who are undergoing withdrawal of life sustaining measures, can donate their organs when they die by a process called donation after circulatory determined death (DCD). However, over 30% of all DCD attempts are unsuccessful because patients do not die within the time frame required for healthy organ retrieval and prolonged exposure to low oxygen during the dying process renders organs unsuitable for transplantation. Predicting successful DCD is difficult and leads to uncertainty in the clinical community. To address this issue, the investigators have developed a clinical decision support tool called Donation Advisor (DA) that will assist the healthcare team in identifying successful DCD donors and will provide an improved assessment of the health of their organs. The investigators are ready to implement DA and evaluate its impact in 7 hospitals in Ontario. The investigators believe use of DA will reduce unsuccessful DCD attempts, enhance family experience of donation, optimize system costs, and improve transplant outcomes
- Conditions
- Organ Donation
- Keywords
- Organ Donation after Circulatory Determined Death (DCD), Clinical Decision Support Tool, Organ Donation, Organ Transplantation, DCD
What is being measured
The primary outcome is the main question the study is designed to answer.
Waveform collection from the bedside monitor
Heart rate, systolic, mean and diastolic blood pressure and oxymetry will be downloaded from the bedside monitor. Automated algorithms will assess the quality of the waveform data, and detect the necessary fiducial markers (R peaks, systolic and diastolic peaks, and pulse pressure measurements), and perform cleaning of artifacts, missing data and noise, to form vital signs time series, which will be used to calculate variability metrics for the patient.
Measured: From date and time of enrollment until the date and time of declaration of death, assessed up to 6 hours post withdrawal of life sustaining measures
Systemic Ischemia
Duration of time when the systolic blood pressure and/or oxygen saturation fall below physiologic thresholds indicating organ ischemia
Measured: From the date and time of withdrawal of life sustaining measures until the date and time of declaration of death, assessed up to 6 hours
Efficacy of DCD outcome prediction by the Donation Advisor (DA) Tool
The predictive capacity of the models to accurately identify time between withdrawal of Life Sustaining Measures (WLSM) and death will be documented.
Measured: From the date and time of withdrawal of life sustaining measures until the date and time of declaration of death, assessed up to 6 hours
Donation Advisor (DA) Tool Report
Time to create the DA Report
Measured: From the date and time the Research Coordinator initiates the report to the date and time the report displays, assessed up to 1 week
Enduser feedback on the Donation Advisor Tool Usability and Feasibility
Data with be collected using 'Thinking aloud interviews' where Health Care Professional with review DA Reports. Data captured: misunderstandings, pauses, repetitions, and expressions of frustration or confusion. These "usability problems" will become target areas for improvements on subsequent versions of the tool. A series of direct questions will allow the interviewee to report on overall usability (clarity, ease of navigation) and usefulness of the tool. They will be asked about the feasibility and usefulness of using a tool like this in their clinical practice, as well as the amount of time one could reasonably expect a physician to spend with a tool like this in their clinical practice, to inform the final design goals for the tool. Finally, interviewees will be asked to report as many potential barriers to and drivers of use of the tool as they can.
Measured: Up to 1 week post declaration of death following withdrawal of life sustaining measures
Success of Organ Transplantations
Including attempted DCD with no organs retrieved, The undergoing of DCD with at least one organ transplanted Number of organs donated per donor Failed organ transplants (i.e. proportion of organs discarded due to excessive warm ischemia time, or that fail after transplant) Proportion of recipients with early transplant graft dysfunction.
Measured: at 28 days from organ transplantation or hospital discharge if sooner than 28 days
Secondary outcomes (1)
Resources and associated costs to further develop and expand implementation of the DA tool
Estimate of required resources and associated costs to further develop and expand implementation of the DA tool - The investigators will assess the economic feasibility of DA tool by calculating the cost of developing and implementing DA tool. A blended micro- and gross- costing approach will be used. The investigators will develop a data collection form to collect resource use for developing, operating, and maintaining the DA tool. Their unit costs will be obtained from program financial records, service level agreements, and the program budget with a close consultation with the project staff
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start11 Jan 2021
- Primary completion31 Aug 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ DonationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Gift of Life, Canadian Blood Services, Health Canada, Canadian National Transplant Research Program, The Physicians' Services Incorporated Foundation, The Ottawa Hospital, Unity Health Toronto, Kingston Health Sciences Centre, London Health Sciences Centre, Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Sonny Dhanani, MD, Principal investigator, CHEO-RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661787
- Sponsor's protocol ID
- 20200360-01T
- Other IDs
- 1920-HQ-000104, PSI Grant Number 19-33, CRRF 2169, CTO Project ID 2117
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Donation Advisor, a Personalized Clinical Decision Support Tool for Improved Efficiency and Effectiveness of Deceased Organ Donation and Transplantation
- ClinicalTrials.gov ID
- NCT04661787
- Acronym / sponsor ID
- 20200360-01T
- Conditions
- Organ Donation
- Keywords
- Organ Donation after Circulatory Determined Death (DCD), Clinical Decision Support Tool, Organ Donation, Organ Transplantation, DCD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Gift of Life, Canadian Blood Services, Health Canada, Canadian National Transplant Research Program, The Physicians' Services Incorporated Foundation, The Ottawa Hospital, Unity Health Toronto, Kingston Health Sciences Centre, London Health Sciences Centre, Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, University Health Network, Toronto
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 10 Dec 2020 (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.
Every year, thousands of Canadians receive life-saving, cost-effective organ transplants, while thousands more still wait or die because not enough organs are available. Patients with non-recoverable illnesses, who are undergoing withdrawal of life sustaining measures, can donate their organs when they die by a process called donation after circulatory determined death (DCD). However, over 30% of all DCD attempts are unsuccessful because patients do not die within the time frame required for healthy organ retrieval and prolonged exposure to low oxygen during the dying process renders organs unsuitable for transplantation. Predicting successful DCD is difficult and leads to uncertainty in the clinical community. To address this issue, the investigators have developed a clinical decision support tool called Donation Advisor (DA) that will assist the healthcare team in identifying successful DCD donors and will provide an improved assessment of the health of their organs. The investigators are ready to implement DA and evaluate its impact in 7 hospitals in Ontario. The investigators believe use of DA will reduce unsuccessful DCD attempts, enhance family experience of donation, optimize system costs, and improve transplant outcomes
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60-80 organ donation patients 180-240 transplant recipients (anticipated average of 3 per donor patient) 30-40 health care professionals to participate in interviews (reviewing the Donation Advisor Tool Reports)
Key inclusion criteria (3 listed)
- for Organ Donation Patients: All patients eligible for DCD and whose substitute decision makers (SDMs) have been approached for consent by a Trillium Organ Tissue Donation Coordinator (OTDC).
- for Organ Transplant Recipient Patients - All patients at any of the Transplant Centres participating in this study who are transplant recipients of the organs from enrolled donor patients.
- for Health Care Professionals for Interviews to provide feedback on the Donation Advisor Tool - All physicians (donation and transplantation), bedside nurses and OTDCs who either have the potential to be involved in the care of study patients, or who been directly involved in the care of the study patients.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Waveform collection from the bedside monitor
Time frame: From date and time of enrollment until the date and time of declaration of death, assessed up to 6 hours post withdrawal of life sustaining measures
Heart rate, systolic, mean and diastolic blood pressure and oxymetry will be downloaded from the bedside monitor. Automated algorithms will assess the quality of the waveform data, and detect the necessary fiducial markers (R peaks, systolic and diastolic peaks, and pulse pressure measurements), and perform cleaning of artifacts, missing data and noise, to form vital signs time series, which will be used to calculate variability metrics for the patient.
Systemic Ischemia
Time frame: From the date and time of withdrawal of life sustaining measures until the date and time of declaration of death, assessed up to 6 hours
Duration of time when the systolic blood pressure and/or oxygen saturation fall below physiologic thresholds indicating organ ischemia
Efficacy of DCD outcome prediction by the Donation Advisor (DA) Tool
Time frame: From the date and time of withdrawal of life sustaining measures until the date and time of declaration of death, assessed up to 6 hours
The predictive capacity of the models to accurately identify time between withdrawal of Life Sustaining Measures (WLSM) and death will be documented.
Donation Advisor (DA) Tool Report
Time frame: From the date and time the Research Coordinator initiates the report to the date and time the report displays, assessed up to 1 week
Time to create the DA Report
Enduser feedback on the Donation Advisor Tool Usability and Feasibility
Time frame: Up to 1 week post declaration of death following withdrawal of life sustaining measures
Data with be collected using 'Thinking aloud interviews' where Health Care Professional with review DA Reports. Data captured: misunderstandings, pauses, repetitions, and expressions of frustration or confusion. These "usability problems" will become target areas for improvements on subsequent versions of the tool. A series of direct questions will allow the interviewee to report on overall usability (clarity, ease of navigation) and usefulness of the tool. They will be asked about the feasibility and usefulness of using a tool like this in their clinical practice, as well as the amount of time one could reasonably expect a physician to spend with a tool like this in their clinical practice, to inform the final design goals for the tool. Finally, interviewees will be asked to report as many potential barriers to and drivers of use of the tool as they can.
Success of Organ Transplantations
Time frame: at 28 days from organ transplantation or hospital discharge if sooner than 28 days
Including attempted DCD with no organs retrieved, The undergoing of DCD with at least one organ transplanted Number of organs donated per donor Failed organ transplants (i.e. proportion of organs discarded due to excessive warm ischemia time, or that fail after transplant) Proportion of recipients with early transplant graft dysfunction.
1 secondary outcome
Resources and associated costs to further develop and expand implementation of the DA tool
Time frame: through study completion, an average of 2 years
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Sonny Dhanani, MD principal investigator
CHEO-RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Donation, run by Ottawa Hospital Research Institute at 1 site 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 3 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Waveform collection from the bedside monitor (time frame: From date and time of enrollment until the date and time of declaration of death, assessed up to 6 hours post withdrawal of life sustaining measures). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.