Primary Graft DysfunctionPROTECT-PGDNCT07230886
Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
A study testing Xo Port Organ Preservation System in people with Primary Graft Dysfunction, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Primary Graft Dysfunction
- What is being tested?
- Xo Port Organ Preservation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recipient: Multi-organ transplant recipients; Participating in an interventional study.
- Donor: Donation after cardiac death; Use of organ care system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Judy Sleek, BSc, 437-676-2974, judy.sleek@uhn.ca
Megha Parashar, MS, Megha.Parashar2@uhn.ca
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Primary Graft Dysfunction
- Being tested
- Xo Port Organ Preservation System, Standard of Care - Ice packs
- Keywords
- Primary Graft Dysfunction, Transplant, Traferox, Preservation Therapy, X Port Preservation System
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xo Port Organ Preservation SystemDevice
Also called Traferox Transport 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.
Standard of Care - Ice packsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Xo Port Organ Preservation System | Experimental | Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage Receives: Device: Xo Port Organ Preservation System |
| Static Ice Storage | Active comparator | Traferox Transport System containing ice-packs as used for conventional cold static storage Receives: Device: Standard of Care - Ice packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Study Feasibility
Determined by the mean number of participants recruited per month calculated on recruitment over 24 months.
Measured: 2.5 years
Composite efficacy outcome of full-scare trial #1
90-day mortality
Measured: 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
Measured: 2.5 years
Composite efficacy outcome of full-scare trial #3
duration of mechanical ventilation
Measured: 2.5 years
Composite efficacy outcome of full-scare trial #4
ICU length of stay (LOS)
Measured: 2.5 years
Composite efficacy outcome of full-scare trial #5
index transplant LOS
Measured: 2.5 years
Composite efficacy outcome of full-scare trial #6
Moderate to severe rejection based on ISHLT criteria at 90 days
Measured: 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
Measured: 2.5 years
Composite efficacy outcome of full-scare trial #8
cfDNA count measured over POD0, POD1, and POD7
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start17 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, feasibility, randomized, blinded, controlled pilot trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- CareDx, Montreal Heart Institute, London Health Sciences Centre, Ottawa Heart Institute Research Corporation, Traferox Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Yasbanoo Moayedi, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230886
- Sponsor's protocol ID
- 25-5039
- Acronym
- PROTECT-PGD
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
- ClinicalTrials.gov ID
- NCT07230886
- Acronym / sponsor ID
- PROTECT-PGD / 25-5039
- Conditions
- Primary Graft Dysfunction
- Keywords
- Primary Graft Dysfunction, Transplant, Traferox, Preservation Therapy, X Port Preservation System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- CareDx, Montreal Heart Institute, London Health Sciences Centre, Ottawa Heart Institute Research Corporation, Traferox Technologies Inc.
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- multicentre, feasibility, randomized, blinded, controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Xo Port Organ Preservation System | Experimental | Device: Xo Port Organ Preservation SystemTraferox Transport System containing eutectic gel-packs used for controlled hypothermic storage |
| Static Ice Storage | Active comparator | Device: Standard of Care - Ice packsTraferox Transport System containing ice-packs as used for conventional cold static storage |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Recipient: Multi-organ transplant recipients; Participating in an interventional study.
- Donor: Donation after cardiac death; Use of organ care system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xo Port Organ Preservation SystemAlso: Traferox Transport SystemIt 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. | Device | Xo Port Organ Preservation System |
| Standard of Care - Ice packsCold 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. | Device | Static Ice Storage |
Primary outcome
Primary Study Feasibility
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Related trials for Primary Graft Dysfunction
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Evaluation of Patients With Immune Function Abnormalities
Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID)
Not yet recruiting
Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.
Urethral Stricture, Erectile Dysfunction
RecruitingObservational study
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
Active, not recruitingObservational study
Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasbanoo Moayedi, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xo Port Organ Preservation System in people with Primary Graft Dysfunction, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy Sleek, BSc. (437-676-2974, judy.sleek@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Study Feasibility (time frame: 2.5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.