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NOT YET RECRUITING
NCT07903428
NA

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

Sponsor: OBS Medical Ltd

View on ClinicalTrials.gov

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.

Official title: Improving Deceased Organ Donation and Transplantation: a Multicentre Feasibility Implementation Randomized Controlled Trial of the Donation Advisor Clinical Decision Support Tool

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2027-01-01

Completion Date

2028-08-01

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DEVICE

Donation Advisor clinical decision-support tool

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.