10°C vs 4°C Lung Preservation RCT
Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jun 9, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
**Clinical Trial Summary: 10°C vs 4°C Lung Preservation**
This clinical trial is investigating a new method for preserving donor lungs before transplantation. Currently, lungs are stored on ice at around 4°C, but researchers believe that storing them at 10°C might be better for keeping the organs healthy. The goal is to see if this warmer temperature can reduce a serious complication called Primary Graft Dysfunction (PGD), which can happen soon after the transplant and affects many patients. By comparing the two preservation methods, the trial hopes to find out if the 10°C method could lead to better outcomes for patients receiving lung transplants.
To participate in the trial, donors must meet specific criteria, including being brain-dead or having just died, and their lungs should be suitable for immediate transplant without needing additional assessments. Recipients need to be between 18 and 80 years old and are required to be receiving their first lung transplant. If you or a loved one is considering a lung transplant and meets these criteria, this trial could provide important insights into improving lung preservation and potentially enhancing transplant success. Participants can expect to be monitored for a year after the transplant to evaluate their recovery and lung function.
Gender
ALL
Eligibility 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
About University Health Network, Toronto
University Health Network (UHN), based in Toronto, is a leading academic health sciences center dedicated to advancing patient care through innovative research and education. As a prominent sponsor of clinical trials, UHN integrates cutting-edge scientific discoveries with clinical practice, facilitating the development of new therapies and treatment modalities. With a commitment to improving health outcomes, UHN collaborates with a diverse network of researchers, healthcare professionals, and industry partners, fostering an environment that prioritizes patient safety and ethical standards in clinical research. Through its extensive resources and expertise, UHN plays a pivotal role in transforming healthcare and enhancing the quality of life for patients both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Francisco, California, United States
Vienna, , Austria
Coral Gables, Florida, United States
Toronto, Ontario, Canada
Zurich, , Switzerland
Lausanne, , Switzerland
Leuven, , Belgium
Montréal, Quebec, Canada
Madrid, , Spain
Sydney, New South Wales, Australia
Grand Rapids, Michigan, United States
Patients applied
Trial Officials
Elliot Wakeam, MD MPH
Principal Investigator
University Health Network, Toronto
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported