Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xo Port Organ Preservation System, Standard of Care - Ice packs.
- Who it may be relevant to
- Registry conditions: Primary Graft Dysfunction. Basic parameters: from 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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 orga - 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.
Primary outcome measures
- Primary Study Feasibility [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #1 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #2 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #3 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #4 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #5 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #6 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #7 [Time frame: 2.5 years]
- Composite efficacy outcome of full-scare trial #8 [Time frame: 2.5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- University Health Network — Toronto
Identifiers
NCT: NCT07230886 · 25-5039