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Not Yet Recruiting NCT07903428

Improving Deceased Organ Donation and Transplantation Using the Donation Advisor Clinical Decision Support Tool

Conditions: Organ Donation After Circulatory Death, Organ Donation, Clinical Decision Support Tool

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: OBS Medical Ltd

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 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.

Eligibility Criteria

PATIENT INCLUSION/EXCLUSION CRITERIA A. For Donor Patients: Inclusion criteria include 1. All adult (18 years of age or older) patients considered eligible for DCC where: 1. documented decision to pursue WLSM exists AND 2. SOTDs have obtained DCC consent and consent for research approach 2. 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. B. For Donor Patients: Exclusion criteria include: 1. Individuals with a pacemaker 2. Individuals with a ventricular assist device (VAD) 3. Individuals on an extracorporeal membrane oxygenation (ECMO) machine, cardiac pumps, or balloon pumps 4. 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07903428). StuddyBuddy aggregates publicly available trial information.