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Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction

RecruitingNAAges 17 Years - anyAllUniversity Health Network, Toronto
NCT07230886 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 blo

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Recipient: Multi-organ transplant recipients; Participating in an interventional study. * Donor: Donation after cardiac death; Use of organ care system
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What it tests

  • Xo Port Organ Preservation System
  • Standard of Care - Ice packs
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Where

1 site
University Health Network
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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