All studies
Active not recruitingNAINTERVENTIONAL

10°C vs 4°C Lung Preservation RCT

This study is looking at a new way to store donor lungs before a transplant. Currently, lungs are kept on ice (around 4°C). This trial is testing if storing them at a slightly warmer temperature of 10°C works better. The main goal is to reduce a serious complication called Primary Graft Dysfunction (PGD), which affects many lung transplant patients and can lead to problems immediately after surgery. If successful, this new method could lead to more successful transplants, allow for longer storage times (meaning more flexibility for scheduling surgeries), and ultimately improve the health and recovery of people receiving new lungs. Researchers are comparing the new 10°C method to the standard ice storage method in 300 patients across different hospitals.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University Health Network, Toronto
Enrolment target
317
Start
09 Jun 2023
Estimated completion
22 Nov 2026

What is this study about?

When someone needs a new lung, the donor lung needs to be kept in the best possible condition before transplant surgery. Currently, this usually means keeping the lung very cold, on ice at about 4°C. While this helps preserve the lung, there are limits to how long it can be stored this way, usually only 6-8 hours. Also, sometimes keeping the lung too cold can still lead to problems after the transplant.

This new study is exploring whether a slightly warmer temperature of 10°C might be better for storing donor lungs. Previous research has hinted that 10°C could be the 'sweet spot' – warm enough to avoid some of the issues of being too cold, but still cool enough to protect the delicate lung tissue. If effective, this could mean donor lungs can be stored safely for longer periods. This extra time would be incredibly helpful, allowing more flexibility in scheduling operations, giving surgeons more time to prepare, and making it easier to match a donor lung with the right recipient.

The main aim of this study is to see if storing lungs at 10°C reduces a common and serious problem called Primary Graft Dysfunction (PGD). PGD happens in about a quarter of lung transplant patients and can cause severe lung injury soon after the transplant, leading to longer hospital stays and affecting long-term health. By comparing donor lungs stored at 10°C versus the standard 4°C, researchers hope to find a way to make lung transplants even safer and more successful for patients.

Key takeaways

  • Exploring if a new lung storage temperature (10°C) is better than standard ice (4°C).
  • Aims to reduce a serious complication called Primary Graft Dysfunction (PGD).
  • Could lead to safer transplants and more flexibility in scheduling surgeries.
  • Compares outcomes for 300 patients over one year after transplant.
  • Only for first-time, adult, double lung transplant recipients.

Who may be eligible?

To be able to take part in this study, you would need to be an adult between 18 and 80 years old, who is having their first-ever lung transplant, specifically a transplant of both lungs. This study is not for people who have had a lung transplant before, are having other organs transplanted at the same time, or are only having one lung transplanted.

For the donor lungs, they need to be strong and healthy enough to be used directly for a transplant. This means they shouldn't need any special extra testing or treatment before being transplanted. Our medical team will carefully check all criteria for both the recipient and the donor lung to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 80 years old?
  2. Is this your first lung transplant?
  3. Will you be having both lungs transplanted?
  4. Are you NOT having any other organs transplanted at the same time?
Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in this study, the main difference for you will be how your new donor lungs are kept before your transplant surgery. Instead of the usual ice cooler, your lungs might be kept in a special device that maintains a temperature of about 10°C. Everything else about your transplant surgery and immediate care will be the same as standard practice. Researchers will then closely monitor your health and how your new lungs are working for one year after the transplant. This will involve regular check-ups and tests, similar to what you would have anyway after a lung transplant, to see how well you are recovering and how your lungs are functioning.

Potential risks and benefits

Taking part in this study might mean that the way your new donor lungs are stored is different from the usual method. While initial research suggests this new temperature is safe, there's always a possibility that it may not offer additional benefits or could have unknown effects, though this is carefully monitored. The potential benefit is that this new storage method could lead to fewer complications like Primary Graft Dysfunction, better recovery, and improved long-term health after your lung transplant. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (17)

  • Dignity Health (St. Joseph's Hospital and Medical Center)
    Verified postcode
    Phoenix, United States
  • University of California San Francisco
    Verified postcode
    San Francisco, United States
  • University of Miami
    Verified postcode
    Coral Gables, United States
  • Corewell Health Research Institute
    Verified postcode
    Grand Rapids, United States
  • Mayo Clinic
    Verified postcode
    Rochester, United States
  • Vanderbilt University Medical Center
    Verified postcode
    Nashville, United States
  • University of Texas Southwestern Medical Center
    Verified postcode
    Dallas, United States
  • St Vincent's Hospital Sydney Limited
    Verified postcode
    Sydney, Australia
  • Medical University of Vienna
    Verified postcode
    Vienna, Austria
  • University Hospitals Leuven
    Verified postcode
    Leuven, Belgium
  • University Health Network (Toronto General Hospital)
    Verified postcode
    Toronto, Canada
  • Centre hospitalier de l'Université de Montréal
    Verified postcode
    Montreal, Canada

Common questions

What is Primary Graft Dysfunction (PGD)?

PGD is a serious complication that can happen shortly after a lung transplant where the new lungs don't work as well as they should, causing breathing difficulties.

What is the usual way donor lungs are stored?

Donor lungs are usually kept very cold, around 4°C, in a cooler with ice to preserve them before surgery.

Why is 10°C being tested?

Previous research suggests that 10°C might be a better temperature, potentially reducing damage to the lungs and allowing them to be stored safely for longer.

Will my everyday care be different if I join this study?

Apart from the way the donor lungs are stored, your surgery and aftercare will be the same as usual. You'll have regular follow-up appointments and tests.

Can I choose not to be part of the study?

Yes, taking part is completely voluntary. Your decision will not affect the quality of your care or your chances of receiving a lung transplant.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.