An interventional study of Donation Advisor clinical decision-support tool in Organ Donation After Circulatory Death, Organ Donation and Clinical Decision Support Tool, sponsored by OBS Medical Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by OBS Medical Ltd · Not applicable, Interventional, and Other
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 10 is below the median of 163 across 210 interventional studies indexed under Death.
Browse Death studies →OBS Medical Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
B. For Donor Patients: Exclusion criteria include:
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.
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: Donation Advisor clinical decision-support tool
DA reports will be generated for patients in the control arm however, no reports will be disseminated to clinicians prior to and following WLSM.
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.
Also known as: DA Tool, DA
Enrolment
(i) Average enrolment of 1 patient/centre/2 months
Time frame: 12 months
Consent rate
(ii) We will target a consent rate of \> 90%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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.
Time frame: 12 months
Outcome Data Collection (a)
(a) proportion of patients consented for DCC that proceed to DCC attempt
Time frame: 18 months
Outcome Data Collection (b)
(b) proportion of successful and unsuccessful DCC attempts
Time frame: 18 months
Outcome Data Collection (c)
(c) time to death of all patients consented for DCC
Time frame: 18 months
Outcome Data Collection (d)
(d) organs retrieved
Time frame: 18 months
Outcome Data Collection (e)
(e) organs transplanted
Time frame: 18 months
Outcome Data Collection (f)
(f) organs functional at 90 days
Time frame: 18 months
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.
Time frame: 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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