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

University Health Network, Toronto

Status: Not yet enrolling

Conditions: Primary Graft Dysfunction

Treatments: Device: Standard of Care - Ice packs; Device: Xo Port Organ Preservation System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07230886

25-5039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Xo Port Organ Preservation System

Experimental group

Description:

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

Treatment:

Device: Xo Port Organ Preservation System

Static Ice Storage

Active Comparator group

Description:

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

Treatment:

Device: Standard of Care - Ice packs