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Could storing lungs at 10°C improve transplant outcomes?

NCT ID NCT05898776

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether storing donor lungs at 10°C instead of the usual ice cooler reduces severe lung injury after transplant. About 300 people receiving a lung transplant will be randomly assigned to one of two storage methods. The main goal is to see if the 10°C method is at least as safe as the standard ice method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
10°C lung preservation using X°Port Lung Transport Device
What this could lead to
If this works, it could reduce the risk of severe lung injury after transplant and allow safer, longer storage times for donor lungs.
What could go wrong
This is a non-inferiority trial, so it may only show that 10°C storage is as safe as ice, not better. The results may not apply to all donor lungs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

317 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung transplant Organ preservation

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Switzerland

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X0A9, Canada

  • Corewell Health Research Institute

    Grand Rapids, Michigan, 49503, United States

  • Dignity Health (St. Joseph's Hospital and Medical Center)

    Phoenix, Arizona, 85050, United States

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Madrid, Spain

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of Vienna

    Vienna, Austria

  • St Vincent's Hospital Sydney Limited

    Sydney, New South Wales, 2010, Australia

  • The Saint Joseph Hospital Foundation (Hôpital Marie Lannelongue)

    Paris, 75014, France

  • University Health Network (Toronto General Hospital)

    Toronto, Ontario, M5G 2C4, Canada

  • University Hospital Zurich

    Zurich, Switzerland

  • University Hospitals Leuven

    Leuven, Belgium

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Miami

    Coral Gables, Florida, 33146, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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