The goal of this clinical trial is to test the feasibility of the study protocol comparing a novel temperature control system - Xo Port Organ Preservation System - to static ice for heat preservation for Heart Transplant. The main questions of the study are as follows:
Does the Incidence of severe PGD change within the first 24 hours of heart transplant in patients randomized to the Xo Port Organ Preservation System?
Was there a change in composite efficacy endpoints in participants randomized to the Xo Port Organ Preservation System compared to static ice storage?
Were the feasibility outcomes achieved?
Were there any protocol deviations?
Participants will:
Be randomized to either the Xo Port Organ Preservation System or static ice storage.
Complete a questionnaire at the time of screening, day 0, 7, and 90 days post transplant.
Have blood drawn - with their standard of care blood draws - after their transplant, the day after, and 7 days post transplant.
Recipient: Adult (>17 years old)
Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance
Recipient: Multi-organ transplant recipients; Participating in an interventional study.
Donor: Donation after cardiac death; Use of organ care system
University Health Network, Toronto
Lead sponsor
CareDx
Collaborator
Montreal Heart Institute
Collaborator
London Health Sciences Centre
Collaborator
Ottawa Heart Institute Research Corporation
Collaborator
Traferox Technology Inc.
Collaborator