Organ Donation After Circulatory DeathDARTNCT07903428
Improving Deceased Organ Donation and Transplantation Using the Donation Advisor Clinical Decision Support Tool
A study testing Donation Advisor clinical decision-support tool in people with Organ Donation After Circulatory Death and Organ Donation, run by OBS Medical Ltd.
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?
- Ages 18 years and older
- Conditions the study is for
- Organ Donation After Circulatory Death, Organ Donation, Clinical Decision Support Tool
- What is being tested?
- Donation Advisor clinical decision-support tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PATIENT INCLUSION/EXCLUSION CRITERIA A. For Donor Patients: Inclusion criteria include
- All adult (18 years of age or older) patients considered eligible for DCC where:
- documented decision to pursue WLSM exists AND
- SOTDs have obtained DCC consent and consent for research approach
- All patients at any of the Transplant Centres participating in this study who are transplant recipients of the organs from enrolled donors as per 1.
- For Donor Patients: Exclusion criteria include:
- Individuals with a pacemaker
- Individuals with a ventricular assist device (VAD)
- Individuals on an extracorporeal membrane oxygenation (ECMO) machine, cardiac pumps, or balloon pumps
- Individuals participating in medical assistance in dying (MAID)
There are no exclusion criteria for Organ Transplant recipient patients.
CLINICIAN INCLUSION/EXCLUSION CRITERIA Inclusion criteria include all clinicians who either are involved in the care of study patients or in the donation-transplant process and may have been exposed to a report.
Clinicians that are in the control arm will not be included. There are no other exclusion criteria for the clinicians.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Deceased Organ Donation and Transplantation: a Multicentre Feasibility Implementation Randomized Controlled Trial of the Donation Advisor Clinical Decision Support Tool
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 death determination by circulatory criteria (DCC), previously known as donation after circulatory determined death (DCD). However, over 30% of all DCC 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 DCC 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) designed to assist with donation and transplantation decision making. The investigators are ready to implement DA in at least four hospitals in Ontario and evaluate its impact in these hospitals. An additional hospital will be participating solely as a transplant centre. The investigators believe use of DA will reduce unsuccessful DCC attempts, enhance family experience of donation, optimize system costs, and improve transplant outcomes.
- Being tested
- Donation Advisor clinical decision-support tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donation Advisor clinical decision-support toolDevice
Also called DA Tool, DA
This intervention involves generation of DA reports that are disseminated to the clinicians in involved in the donor patients care and organ donation. This decision aide will be installed on a Windows-based laptop with data acquisition software pre-installed and configured for the collection of vital sign waveform data from bedside monitors via a serial or LANconnection, depending on what is available at each of the participating sites. Demographic and clinical data from DCC donors enrolled in the study will be collected by a member of the research team using the DA tool data entry interface during the donation process. The DA tool will generate pre- and post-WLSM reports that will be delivered to clinicians during the DCC process for all patients in Phase 1 and all patients in the intervention arm for Phase 2.
| Study group | Role | What they receive |
|---|---|---|
| Integrative | Experimental | Demographic and clinical data from DCC donors enrolled in the study will be collected by a member of the research team using the DA tool data entry interface during the donation process. The DA tool will generate pre- and post-WLSM reports that will be delivered to clinicians during the DCC process for all patients in Phase 1 and all patients in the intervention arm for Phase 2. Receives: Device: Donation Advisor clinical decision-support tool |
| Control | No intervention | DA reports will be generated for patients in the control arm however, no reports will be disseminated to clinicians prior to and following WLSM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrolment
(i) Average enrolment of 1 patient/centre/2 months
Measured: 12 months
Consent rate
(ii) We will target a consent rate of > 90%.
Measured: 12 months
Protocol adherence
(iii) We will target > 96% protocol adherence defined by successful predictive model and DA report generation, for both the preWLSM and postWLSM reports, with red light upper cutoffs of 70%.
Measured: 12 months
DA report delivery (a)
(iv) a) We will target >96% confirmed delivery of DA report to at least one transplant physician and donation physician to assist clinical decision-making in the intervention arm, for both the preWLSM and postWLSM reports, with red light upper cutoffs of 70%.
Measured: 12 months
DA report delivery (b)
(iv) b) We will target >85% successful generation and delivery (to at least one transplant physician and donation physician) of both reports, with a red-light upper cutoff of 58%.
Of the primary outcome measurements, this applies only to the intervention arm.
Measured: 12 months
Outcome Data Collection (a)
(a) proportion of patients consented for DCC that proceed to DCC attempt
Measured: 18 months
Outcome Data Collection (b)
(b) proportion of successful and unsuccessful DCC attempts
Measured: 18 months
Outcome Data Collection (c)
(c) time to death of all patients consented for DCC
Measured: 18 months
Outcome Data Collection (d)
(d) organs retrieved
Measured: 18 months
Outcome Data Collection (e)
(e) organs transplanted
Measured: 18 months
Outcome Data Collection (f)
(f) organs functional at 90 days
Measured: 18 months
Secondary outcomes (1)
Identify stakeholder barriers and drivers for DA implementation (qualitative outcome)
The secondary objective of the study is to identify stakeholder barriers and drivers for DA implementation. This will be done by assessing experiences and opinions from four clinician teams exposed to DA, identifying barriers, drivers, and utility perceptions through interviews based on the TFA and GUIDES checklist.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Donation After Circulatory DeathStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This two-phase study will begin with a multicentre feasibility implementation study of DA in phase 1, followed by a patient-level feasibility randomized controlled trial in phase 2.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OBS Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gift of Life, Canadian Blood Services, Health Canada, Canadian Institutes of Health Research (CIHR), The Ottawa Hospital, Sunnybrook Health Sciences Centre, Kingston Health Sciences Centre, London Health Sciences Centre, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Andrew JE Seely, MD, PhD, FRCSC, Principal investigator, The Ottawa Hospital, The Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903428
- Sponsor's protocol ID
- 6025
- Acronym
- DART
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Deceased Organ Donation and Transplantation: a Multicentre Feasibility Implementation Randomized Controlled Trial of the Donation Advisor Clinical Decision Support Tool
- ClinicalTrials.gov ID
- NCT07903428
- Acronym / sponsor ID
- DART / 6025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- OBS Medical LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gift of Life, Canadian Blood Services, Health Canada, Canadian Institutes of Health Research (CIHR), The Ottawa Hospital, Sunnybrook Health Sciences Centre, Kingston Health Sciences Centre, London Health Sciences Centre, University Health Network, Toronto
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Oct 2026 (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 death determination by circulatory criteria (DCC), previously known as donation after circulatory determined death (DCD). However, over 30% of all DCC 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 DCC 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) designed to assist with donation and transplantation decision making. The investigators are ready to implement DA in at least four hospitals in Ontario and evaluate its impact in these hospitals. An additional hospital will be participating solely as a transplant centre. The investigators believe use of DA will reduce unsuccessful DCC attempts, enhance family experience of donation, optimize system costs, and improve transplant outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This two-phase study will begin with a multicentre feasibility implementation study of DA in phase 1, followed by a patient-level feasibility randomized controlled trial in phase 2.
| Arm | Type | Receives |
|---|---|---|
| Integrative | Experimental | Device: Donation Advisor clinical decision-support toolDemographic and clinical data from DCC donors enrolled in the study will be collected by a member of the research team using the DA tool data entry interface during the donation process. The DA tool will generate pre- and post-WLSM reports that will be delivered to clinicians during the DCC process for all patients in Phase 1 and all patients in the intervention arm for Phase 2. |
| Control | No intervention | –DA reports will be generated for patients in the control arm however, no reports will be disseminated to clinicians prior to and following WLSM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Donation Advisor clinical decision-support toolAlso: DA Tool, DAThis intervention involves generation of DA reports that are disseminated to the clinicians in involved in the donor patients care and organ donation. This decision aide will be installed on a Windows-based laptop with data acquisition software pre-installed and configured for the collection of vital sign waveform data from bedside monitors via a serial or LANconnection, depending on what is available at each of the participating sites. Demographic and clinical data from DCC donors enrolled in the study will be collected by a member of the research team using the DA tool data entry interface during the donation process. The DA tool will generate pre- and post-WLSM reports that will be delivered to clinicians during the DCC process for all patients in Phase 1 and all patients in the intervention arm for Phase 2. | Device | Integrative |
Primary outcome
Enrolment
Time frame: 12 months
(i) Average enrolment of 1 patient/centre/2 months
Consent rate
Time frame: 12 months
(ii) We will target a consent rate of > 90%.
Protocol adherence
Time frame: 12 months
(iii) We will target > 96% protocol adherence defined by successful predictive model and DA report generation, for both the preWLSM and postWLSM reports, with red light upper cutoffs of 70%.
DA report delivery (a)
Time frame: 12 months
(iv) a) We will target >96% confirmed delivery of DA report to at least one transplant physician and donation physician to assist clinical decision-making in the intervention arm, for both the preWLSM and postWLSM reports, with red light upper cutoffs of 70%.
DA report delivery (b)
Time frame: 12 months
(iv) b) We will target >85% successful generation and delivery (to at least one transplant physician and donation physician) of both reports, with a red-light upper cutoff of 58%. Of the primary outcome measurements, this applies only to the intervention arm.
Outcome Data Collection (a)
Time frame: 18 months
(a) proportion of patients consented for DCC that proceed to DCC attempt
Outcome Data Collection (b)
Time frame: 18 months
(b) proportion of successful and unsuccessful DCC attempts
Outcome Data Collection (c)
Time frame: 18 months
(c) time to death of all patients consented for DCC
Outcome Data Collection (d)
Time frame: 18 months
(d) organs retrieved
Outcome Data Collection (e)
Time frame: 18 months
(e) organs transplanted
Outcome Data Collection (f)
Time frame: 18 months
(f) organs functional at 90 days
1 secondary outcome
Identify stakeholder barriers and drivers for DA implementation (qualitative outcome)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Organ Donation After Circulatory Death
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
Active, not recruiting
DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors
Organ Transplant
RecruitingObservational study
Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
Organ Transplant
RecruitingObservational study
Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures
Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion
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.
Andrew JE Seely, MD, PhD, FRCSC principal investigator
The Ottawa Hospital, The Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Donation Advisor clinical decision-support tool in people with Organ Donation After Circulatory Death and Organ Donation, run by OBS Medical Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dora Kusevic, BSc (6137-737-8899 ext. 74020, dkusevic@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrolment (time frame: 12 months). The study lists 11 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 29 Oct 2026.