NCT Number: NCT07230886
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.
Interested in participating?
Request Info17 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2C4, Canada
Location status: Recruiting
Judy Sleek, BSc
CONTACT
Megha Parashar, MS
CONTACT
Seyed Rabi
SUB_INVESTIGATOR
Vivek Rao
SUB_INVESTIGATOR
Yasbanoo Moayedi
PRINCIPAL_INVESTIGATOR
The PROTECT-PGD Pilot trial is a 2.5 year, 50-patient, multi-centre, feasibility, randomized, blinded, controlled pilot trial assessing feasibility of a full-scale blinded randomized controlled trial to determine whether use of the Xo Port Organ Preservation System (Traferox Technologies Inc.), a novel temperature controlled system that maintains donor heart temperature between 8 and 12°C reduces the risk of severe PGD in patients post HT. If feasibility is demonstrated, pilot trial participants will be included in the full-scale trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is a disposable temperature-controlled hypothermic transportation system that maintains the donated heart temperature between 8 and 12°C. It consists of an insulated chamber; eutectic gel packs containing a specialized phase change material (composition under manufacturer's patent) preconditioned before use (by freezing in a 4°C temperature-regulated refrigerator for 48 hours), which maintain temperature between 8 and 12°C through passive cooling; a removable insert, a cradle to hold the organ bag, an internal temperature probe; a logger for continuous monitoring and maintenance of temperature over an extended period of time, an internal venting system that allows air circulation to ensure homogenous temperature for a validated maximal time of 24 hours; and casters and a telescopic handle to facilitate transport.
Other names: Traferox Transport System
Cold static donor heart preservation is currently the mainstay of organ transportation after procurement. The donor heart is placed in the Traferox Transport system with ice-packs.
Time frame: 2.5 years
Determined by the mean number of participants recruited per month calculated on recruitment over 24 months.
Time frame: 2.5 years
90-day mortality
Time frame: 2.5 years
severe PGD (defined through the ISHLT consensus definition need for MCS will be adjudicated in a blinded fashion with LVEF<40% and CI<2.0 on high dose inotropes
Time frame: 2.5 years
duration of mechanical ventilation
Time frame: 2.5 years
ICU length of stay (LOS)
Time frame: 2.5 years
index transplant LOS
Time frame: 2.5 years
Moderate to severe rejection based on ISHLT criteria at 90 days
Time frame: 2.5 years
change in EQ-5D-5L utility index score from baseline to 90 days with a clinically meaningful change defined as >0.05
Time frame: 2.5 years
cfDNA count measured over POD0, POD1, and POD7
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Acronym: PROTECT-PGD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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