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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05898776
Registration number
NCT05898776
Ethics application status
Date submitted
31/05/2023
Date registered
12/06/2023
Date last updated
12/06/2025
Titles & IDs
Public title
10°C vs 4°C Lung Preservation RCT
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Scientific title
Safety of 10°C Lung Preservation vs. Standard of Care: A Multi-Centre Prospective Non-Inferiority Trial
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Secondary ID [1]
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22-5909
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Transplant
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Organ Preservation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Lung transplantation after 10°C donor lung preservation
Treatment: Devices - Lung transplantation after standard ice cooler donor lung preservation
Experimental: 10°C lung preservation -
Active comparator: Standard lung preservation -
Treatment: Devices: Lung transplantation after 10°C donor lung preservation
When suitable donor lungs become available for a, eligible, consented recipient and meet criteria to go straight to transplantation, the lungs randomized to 10°C preservation will be stored, transported and preserved in the X°Port Lung Transport Device (Traferox Technologies Inc.) until implant with a maximum time of 12 hours between the donor and recipient surgeries.
Treatment: Devices: Lung transplantation after standard ice cooler donor lung preservation
When suitable donor lungs become available for a, eligible, consented recipient and meet criteria to go straight to transplantation, the lungs randomized to standard preservation will be will be stored, transported and preserved in an ice cooler (\~4°C, standard of care) until implant with a maximum time of 6 hours between the donor and recipient surgeries.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Primary Graft Dysfunction (PGD) Grade 3 as per International Society for Heart and Lung Transplantation (ISHLT)
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Assessment method [1]
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PGD is graded on a scale of 0 to 3 based on ISHLT guidelines, where PGD Grade 3 indicates severe primary graft dysfunction.
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Timepoint [1]
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72 hours post-transplant
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Secondary outcome [1]
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Incidence of Primary Graft Dysfunction Grade 2-3 as per International Society for Heart and Lung Transplantation
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Assessment method [1]
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PGD is graded on a scale of 0 to 3 based on ISHLT guidelines, where PGD Grade 3 indicates severe primary graft dysfunction.
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Timepoint [1]
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0 (ICU arrival), 24, 48, and 72 hours post-transplant
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Secondary outcome [2]
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Time on ventilator
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Assessment method [2]
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Timepoint [2]
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Index hospitalization (up to 1 year)
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Secondary outcome [3]
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Total ICU and hospital length of stay
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Assessment method [3]
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Timepoint [3]
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Index hospitalization (up to 1 year)
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Secondary outcome [4]
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Overall survival
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Assessment method [4]
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Timepoint [4]
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30 days, 1 year post-transplant
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Secondary outcome [5]
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Occurrence of acute rejection
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Assessment method [5]
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Timepoint [5]
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1 year post-transplant
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Secondary outcome [6]
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Six minute walk test
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Assessment method [6]
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Timepoint [6]
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1 year post-transplant
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Secondary outcome [7]
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Forced expiratory volume - one second (FEV1 in L)
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Assessment method [7]
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Timepoint [7]
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1 year post-transplant
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Eligibility
Key inclusion criteria
Donor Inclusion Criteria
* Donation after brain death (DBD) or donation after cardiac death (DCD)
* Donor lungs are suitable to go straight to LTx (i.e., do not need ex vivo lung perfusion (EVLP) assessment)
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* Concerns with organ preservation technique
* Need for EVLP assessment
Recipient Inclusion Criteria
* 18-80 years old
* Primary lung transplantation
* Bilateral lung transplantation
Recipient Exclusion Criteria
* Re-transplantation
* Multi-organ transplantation
* Single lung transplantation
* Participation in a contraindicating trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent's Hospital Sydney Limited - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Florida
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Tennessee
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United States of America
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Texas
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Austria
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State/province [7]
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Vienna
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Belgium
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State/province [8]
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Leuven
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Country [9]
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Canada
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State/province [9]
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Ontario
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Canada
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State/province [10]
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Quebec
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Spain
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Madrid
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Switzerland
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State/province [12]
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Lausanne
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Country [13]
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Switzerland
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State/province [13]
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Zurich
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Health Network, Toronto
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Medical University of Vienna
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Vanderbilt University
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Puerta de Hierro University Hospital
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Address [3]
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Other collaborator category [4]
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Other
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University of California, San Francisco
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Other
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Centre Hospitalier Universitaire Vaudois
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Other collaborator category [6]
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Other
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Mayo Clinic
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Other collaborator category [7]
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Other
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St Vincent's Hospital, Sydney
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Address [7]
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Other collaborator category [8]
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Other
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University of Texas Southwestern Medical Center
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Other collaborator category [9]
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Other
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Spectrum Health Hospitals
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Other collaborator category [10]
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Other
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University of Miami
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Other collaborator category [11]
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Other
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University Hospital of Leuven Leuven
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Other
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Centre hospitalier de l'Université de Montréal (CHUM)
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Other collaborator category [13]
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Other
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University Hospital, Zürich
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Ethics approval
Ethics application status
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Summary
Brief summary
Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbidity, affecting \~25% of lung transplant patients. Induced by ischemia reperfusion, PGD represents a severe and acute lung injury that occurs within the first 72 hours after transplantation, and has a significant impact on short- and long-term outcomes, and a significant increase in treatment costs. Any intervention that reduces the risk of PGD will lead to major improvements in short- and long-term transplant outcomes and health care systems. One of the main strategies to reduce the risk and severity of post-transplant PGD is to improve pre-transplant donor lung preservation methods. In current practice, lung preservation is typically performed by cold flushing the organ with a specialized preservation solution, followed by subsequent hypothermic storage on ice (\~4°C). This method continues to be used and applied across different organ systems due to its simplicity and low cost. Using this method for the preservation of donor lungs, the current maximum accepted preservation times have been limited to approximately 6-8h. While the goal of hypothermic storage is to sustain cellular viability during ischemic time through reduced cellular metabolism, lower organ temperature has also been shown to progressively favor mitochondrial dysfunction. Therefore, the ideal temperature for donor organ preservation remains to be defined and should maintain a balance between avoidance of mitochondrial dysfunction and prevention of cellular exhaustion. In addition to that, safe and longer preservation times can lead to multiple advantages such as moving overnight transplants to daytime, more flexibility to transplant logistics, more time for proper donor to recipient matching etc. Building on pre-clinical research suggesting that 10°C may be the optimal lung storage temperature, a prospective, multi-center, non-randomized clinical trial was conducted at University Health Network, Medical University of Vienna and Puerta de Hierro Majadahonda University Hospital. Donor lungs meeting criteria for direct transplantation and with cross clamp times between 6:00pm - 4:00am were intentionally delayed to an earliest allowed start time of 6:00am and a maximum preservation time from donor cold flush to recipient anesthesia start time of 12 hours. Lungs were retrieved and transported in the usual fashion using a cooler with ice and transferred to a 10°C temperature-controlled cooler upon arrival to transplant hospital until implantation. The primary outcome of this study was incidence of Primary Graft Dysfunction (PGD) Grade 3 at 72h, with secondary endpoints including: recipient time on the ventilator, ICU Length of Stay (LOS), hospital LOS, 30-day survival and lung function at 1-year. Outcomes were compared to a contemporaneous conventionally transplanted recipient cohort using propensity score matching at a 1:2 ratio. 70 patients were included in the study arm. Post-transplant outcomes were comparable between the two groups for up to 1 year. Thus, intentional prolongation of donor lung preservation at 10°C was shown to be clinically safe and feasible. In the current study design, the investigators will conduct a multi-centre, non-inferiority, randomized, controlled trial of 300 participants to compare donor lung preservation from the time of explant to implant at \~10°C in X°Port Lung Transport Device (Traferox Technologies Inc.) vs a standard ice cooler. When eligible donor lungs become available for a consented recipient, the lungs will be randomized to undergo a preservation protocol using either 10°C (X°Port Lung Transport Device, Traferox Technologies Inc.) or standard of care. The primary outcome of the study is incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours. Post-transplant outcomes will be followed for one year.
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Trial website
https://clinicaltrials.gov/study/NCT05898776
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Elliot Wakeam, MD MPH
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Address
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University Health Network, Toronto
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Fax
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Email
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Contact person for public queries
Name
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Sharaniyaa Balachandran
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Address
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Phone
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416-340-4800
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05898776
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