Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction (PROTECT-PGD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Graft Dysfunction
• Intervention / Treatment: Device: Xo Port Organ Preservation System; Device: Standard of Care - Ice packs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judy Sleek, BSc.; Phone Number: 437-676-2974; Email: judy.sleek@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xo Port Organ Preservation System; Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage	Device: Xo Port Organ Preservation System; 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
Active Comparator: Static Ice Storage; Traferox Transport System containing ice-packs as used for conventional cold static storage	Device: Standard of Care - Ice packs; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Study Feasibility	Determined by the mean number of participants recruited per month calculated on recruitment over 24 months.	2.5 years
Composite efficacy outcome of full-scare trial 1	90-day mortality	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	2.5 years
Composite efficacy outcome of full-scare trial 3	duration of mechanical ventilation	2.5 years
Composite efficacy outcome of full-scare trial 4	ICU length of stay (LOS)	2.5 years
Composite efficacy outcome of full-scare trial 5	index transplant LOS	2.5 years
Composite efficacy outcome of full-scare trial 6	Moderate to severe rejection based on ISHLT criteria at 90 days	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	2.5 years
Composite efficacy outcome of full-scare trial 8	cfDNA count measured over POD0, POD1, and POD7	2.5 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: London Health Sciences Centre; Ottawa Heart Institute Research Corporation; Montreal Heart Institute; CareDx; Traferox Technology Inc.
• Investigators: Principal Investigator: Yasbanoo Moayedi, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Transplant; Primary Graft Dysfunction; Traferox; Preservation Therapy; X Port Preservation System
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Reperfusion Injury; Pathological Conditions, Signs and Symptoms; Primary Graft Dysfunction
• Other Study ID Numbers: 25-5039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No