Comparing two temperatures for preserving donor lungs before transplantation
Safety of 10°C Lung Preservation Vs. Standard of Care: a Multi-Centre Prospective Non-Inferiority Trial
This study tests if keeping donor lungs at a warmer temperature of 10°C instead of the usual 4°C can help lung transplant patients have better outcomes and reduce complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT05898776 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of preserving donor lungs at 10°C compared to the standard 4°C method before lung transplantation. The goal is to reduce the risk of primary graft dysfunction (PGD), a common complication that can lead to early mortality and morbidity in lung transplant patients. By improving preservation techniques, the study aims to enhance both short- and long-term outcomes for recipients. The trial involves lung transplantation from donors who meet specific criteria, ensuring that the lungs are suitable for immediate transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who are receiving their first bilateral lung transplant from suitable donors.
Not a fit: Patients who are undergoing re-transplantation, multi-organ transplantation, or single lung transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve lung transplant outcomes and reduce healthcare costs associated with complications.
How similar studies have performed: Previous studies have explored various preservation techniques, but this specific comparison of preservation temperatures is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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) Donor 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
Where this trial is running
San Francisco, California and 7 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- St Vincent's Hospital Sydney Limited — Sydney, New South Wales, Australia (Recruiting)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- University Health Network (Toronto General Hospital) — Toronto, Ontario, Canada (Recruiting)
- Hospital Universitario Puerta de Hierro-Majadahonda — Madrid, Spain (Recruiting)
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Elliot Wakeam, MD MPH — University Health Network, Toronto
- Study coordinator: Sharaniyaa Balachandran
- Email: sharaniyaa.balachandran@uhn.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.