Condition: Primary Graft Dysfunction · Sponsor: University Health Network, Toronto
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.
This description comes directly from the study's public registry record.
Judy Sleek, BSc. · 437-676-2974 · judy.sleek@uhn.ca
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| University Health Network | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07230886