Primary Graft Dysfunction
Conditions
Keywords
Primary Graft Dysfunction, Transplant, Traferox, Preservation Therapy, X Port Preservation System
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.
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
DEVICEXo 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.
DEVICEStandard 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.
Sponsors
University Health Network, Toronto
CareDx
Montreal Heart Institute
London Health Sciences Centre
Ottawa Heart Institute Research Corporation
Traferox Technology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
multicentre, feasibility, randomized, blinded, controlled pilot trial
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Study Feasibility | 2.5 years | Determined by the mean number of participants recruited per month calculated on recruitment over 24 months. |
| Composite efficacy outcome of full-scare trial #1 | 2.5 years | 90-day mortality |
| Composite efficacy outcome of full-scare trial #2 | 2.5 years | 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 |
| Composite efficacy outcome of full-scare trial #3 | 2.5 years | duration of mechanical ventilation |
| Composite efficacy outcome of full-scare trial #4 | 2.5 years | ICU length of stay (LOS) |
| Composite efficacy outcome of full-scare trial #5 | 2.5 years | index transplant LOS |
| Composite efficacy outcome of full-scare trial #6 | 2.5 years | Moderate to severe rejection based on ISHLT criteria at 90 days |
| Composite efficacy outcome of full-scare trial #7 | 2.5 years | change in EQ-5D-5L utility index score from baseline to 90 days with a clinically meaningful change defined as \>0.05 |
| Composite efficacy outcome of full-scare trial #8 | 2.5 years | cfDNA count measured over POD0, POD1, and POD7 |
Countries
Canada
Contacts
CONTACTJudy Sleek, BSc.
PRINCIPAL_INVESTIGATORYasbanoo Moayedi, MD
University Health Network, Toronto
Outcome results
None listed