Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Composite efficacy outcome of full-scare trial #1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Xo Port Organ Preservation System
Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage
Intervention: Xo Port Organ Preservation System (Device)
Static Ice Storage
Traferox Transport System containing ice-packs as used for conventional cold static storage
Intervention: Standard of Care - Ice packs (Device)
Outcomes
Primary Outcomes
Composite efficacy outcome of full-scare trial #1
Time Frame: 2.5 years
90-day mortality
Composite efficacy outcome of full-scare trial #2
Time Frame: 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
Time Frame: 2.5 years
duration of mechanical ventilation
Composite efficacy outcome of full-scare trial #4
Time Frame: 2.5 years
ICU length of stay (LOS)
Composite efficacy outcome of full-scare trial #5
Time Frame: 2.5 years
index transplant LOS
Composite efficacy outcome of full-scare trial #6
Time Frame: 2.5 years
Moderate to severe rejection based on ISHLT criteria at 90 days
Composite efficacy outcome of full-scare trial #7
Time Frame: 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
Time Frame: 2.5 years
cfDNA count measured over POD0, POD1, and POD7
Primary Study Feasibility
Time Frame: 2.5 years
Determined by the mean number of participants recruited per month calculated on recruitment over 24 months.
Secondary Outcomes
No secondary outcomes reported