An interventional study of Xo Port Organ Preservation System and Standard of Care - Ice packs in Primary Graft Dysfunction, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Other
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.
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.
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's planned enrollment of 50 is close to the median of 47 across 11 interventional studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage
Device: Xo Port Organ Preservation System
Traferox Transport System containing ice-packs as used for conventional cold static storage
Device: Standard of Care - Ice packs
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.
Also known as: 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.
Primary Study Feasibility
Determined by the mean number of participants recruited per month calculated on recruitment over 24 months.
Time frame: 2.5 years
Composite efficacy outcome of full-scare trial #1
90-day mortality
Time frame: 2.5 years
Composite efficacy outcome of full-scare trial #2
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
Composite efficacy outcome of full-scare trial #3
duration of mechanical ventilation
Time frame: 2.5 years
Composite efficacy outcome of full-scare trial #4
ICU length of stay (LOS)
Time frame: 2.5 years
Composite efficacy outcome of full-scare trial #5
index transplant LOS
Time frame: 2.5 years
Composite efficacy outcome of full-scare trial #6
Moderate to severe rejection based on ISHLT criteria at 90 days
Time frame: 2.5 years
Composite efficacy outcome of full-scare trial #7
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
Composite efficacy outcome of full-scare trial #8
cfDNA count measured over POD0, POD1, and POD7
Time frame: 2.5 years
Started Apr 2026 (actual). Primary completion is estimated for Mar 2028, 23 months after the start.
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