Study Results
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Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-06-09
2026-07-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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10°C lung preservation
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.
Standard lung preservation
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Donor lungs are suitable to go straight to LTx (i.e., do not need ex vivo lung perfusion (EVLP) assessment)
* 18-80 years old
* Primary lung transplantation
* Bilateral lung transplantation
Exclusion Criteria
* Need for EVLP assessment
* Re-transplantation
* Multi-organ transplantation
* Single lung transplantation
* Participation in a contraindicating trial
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Vanderbilt University
OTHER
Puerta de Hierro University Hospital
OTHER
University of California, San Francisco
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Mayo Clinic
OTHER
St Vincent's Hospital, Sydney
OTHER
University of Texas Southwestern Medical Center
OTHER
Spectrum Health Hospitals
OTHER
University of Miami
OTHER
University Hospital of Leuven Leuven
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
University Hospital, Zürich
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Elliot Wakeam, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University of California San Francisco
San Francisco, California, United States
University of Miami
Coral Gables, Florida, United States
Corewell Health Research Institute
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
St Vincent's Hospital Sydney Limited
Sydney, New South Wales, Australia
Medical University of Vienna
Vienna, , Austria
University Hospitals Leuven
Leuven, , Belgium
University Health Network (Toronto General Hospital)
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, , Spain
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Isabelle Schmitt-Opitz, MD
Role: primary
Other Identifiers
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22-5909
Identifier Type: -
Identifier Source: org_study_id
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