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

NCT07230886 | Not Yet Recruiting DMC

• 1 other identifier: 25-5039
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Graft Dysfunction

Keywords

Primary Graft Dysfunction; Transplant; Traferox; Preservation Therapy; X Port Preservation System

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Xo Port Organ Preservation System

EXPERIMENTAL

Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage

Device: Xo Port Organ Preservation System

Static Ice Storage

ACTIVE COMPARATOR

Traferox Transport System containing ice-packs as used for conventional cold static storage

Device: Standard of Care - Ice packs

Interventions

Xo Port Organ Preservation System DEVICE

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

Xo Port Organ Preservation System

Standard of Care - Ice packs DEVICE

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.

Static Ice Storage

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recipient: Multi-organ transplant recipients; Participating in an interventional study.
• Donor: Donation after cardiac death; Use of organ care system

Sponsors & Collaborators

• University Health Network, Toronto: lead
• CareDx: collaborator
• Montreal Heart Institute: collaborator
• London Health Sciences Centre: collaborator
• Ottawa Heart Institute Research Corporation: collaborator
• Traferox Technology Inc.: collaborator

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasbanoo Moayedi, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Sleek, BSc.

CONTACT

437-676-2974; judy.sleek@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participant and all study personnel will be blinded to the treatment arm the participant is randomized to - with exception to the unblinded research assistant that will be performing the randomization and allocation process.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicentre, feasibility, randomized, blinded, controlled pilot trial

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: November 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-08