Cold Lung Preservation for Lung Transplant

Recruiting at 14 trial locations

Overseen By Sharaniyaa Balachandran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Re-transplantation, Multi-organ, Single lung, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 hours

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for preserving donor lungs for transplants by maintaining them at about 10°C, rather than using ice. The researchers aim to determine if this method can reduce the risk of serious lung problems that often occur within the first three days post-transplant. Suitable participants are those requiring a primary, double lung transplant. By enhancing donor lung preservation, the trial seeks to make lung transplants safer and more successful over time. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could revolutionize lung transplant procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this lung preservation method is safe?

Research has shown that keeping donor lungs at 10°C is safe. Studies have found that storing lungs at this temperature for up to 24 hours does not negatively affect recovery or health shortly after a lung transplant. Recipients of these transplants recovered just as well as those whose lungs were preserved using traditional methods.

Early results also suggest that this 10°C method is as effective as the usual method of storing lungs on ice. Patients who underwent lung transplants with the 10°C method experienced similar health outcomes up to a year after surgery. Based on current evidence, storing lungs at 10°C appears to be a safe and effective option for lung transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new lung preservation technique that could potentially revolutionize lung transplantation. Unlike traditional methods that keep donor lungs on ice, this new approach preserves lungs at a controlled temperature of 10°C. This method could enhance lung viability and function by minimizing cold-induced injury, potentially leading to better outcomes for transplant recipients. By testing this approach, researchers hope to find out if it offers a significant advantage over the standard ice cooler preservation.

What evidence suggests that this trial's lung preservation methods could be effective?

This trial will compare lung transplantation after 10°C donor lung preservation with transplantation after standard ice cooler preservation. Research has shown that maintaining donor lungs at 10°C can significantly improve transplant outcomes. Studies have found this method safe and without negative effects shortly after surgery. It may even lead to similar or better results compared to traditional colder storage. Additionally, this approach facilitates transplant planning, potentially improving donor-recipient matches. Thus, storing lungs at 10°C could enhance both the transplant process and its success. ^{1 2 5 6 7}

Who Is on the Research Team?

Elliot Wakeam, MD MPH

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for lung transplant recipients whose donor lungs are suitable for immediate transplantation without needing extra assessment. Donors can be after brain or cardiac death, but the lungs must not require ex vivo lung perfusion evaluation.

Inclusion Criteria

I have had a double lung transplant.

My organ donation will be after brain or heart stops.

The donor lungs I'm receiving are ready for transplant without needing further assessment.

Exclusion Criteria

Re-transplantation

Participation in a contraindicating trial

I am interested in treatments that save my organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Donor lungs are preserved at either 10°C using the X°Port Lung Transport Device or at standard ice cooler temperatures, followed by transplantation.

12 hours

1 visit (in-person)

Post-transplant Monitoring

Participants are monitored for incidence of Primary Graft Dysfunction (PGD) Grade 3 at 72 hours post-transplant.

72 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recipient time on the ventilator, ICU Length of Stay, hospital Length of Stay, 30-day survival, and lung function at 1-year.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Lung transplantation after 10°C donor lung preservation
• Lung transplantation after standard ice cooler donor lung preservation

Trial Overview

The study compares two methods of preserving donor lungs before a transplant: one uses a new device to keep the lungs at about 10°C, and the other uses standard ice cooler preservation at approximately 4°C. The goal is to see if the new method reduces severe lung injury post-transplant.

How Is the Trial Designed?

Group I: 10°C lung preservation Experimental Treatment 1 Intervention

Group II: Standard lung preservation Active Control 1 Intervention

Lung transplantation after 10°C donor lung preservation is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Lung transplantation after 10°C donor lung preservation for:

• End-stage lung disease

Approved in European Union as Lung transplantation after 10°C donor lung preservation for:

• End-stage lung disease

Approved in United States as Lung transplantation after 10°C donor lung preservation for:

• End-stage lung disease

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Puerta de Hierro University Hospital

Collaborator

Trials

77

Recruited

36,800+

Centre Hospitalier Universitaire Vaudois

Collaborator

Trials

269

Recruited

14,040,000+

St Vincent's Hospital, Sydney

Collaborator

Trials

35

Recruited

10,400+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

University Hospital of Leuven Leuven

Collaborator

Trials

2

Recruited

340+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

University Hospital, Zürich

Collaborator

Trials

89

Recruited

628,000+

Corewell Health West

Collaborator

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Published Research Related to This Trial

In a study involving 37 canine lungs, using cold air storage at 4°C resulted in 100% survival after 4 hours, significantly outperforming conventional ice slush storage, which had only a 17% survival rate.

The cold air storage method also led to better oxygen levels and lower lung water content compared to ice slush, indicating it may be a more effective technique for preserving lungs for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved lung preservation with cold air storage. Kon, ND., Hines, MH., Harr, CD., et al.[2019]

The portable Organ Care System (OCS) Lung device was successfully used to preserve and transport donor lungs in a study involving 12 lung transplant patients, demonstrating its potential for safe organ preservation.

All patients and grafts survived for at least 30 days post-transplant, indicating that the OCS Lung can effectively support high-risk lung transplants, paving the way for further comparative studies against standard preservation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normothermic perfusion of donor lungs for preservation and assessment with the Organ Care System Lung before bilateral transplantation: a pilot study of 12 patients. Warnecke, G., Moradiellos, J., Tudorache, I., et al.[2022]

Preserving donor lungs at 10°C may significantly extend the cold ischemia time, which is crucial for successful lung transplants, potentially improving transplant logistics.

The report discusses two lung transplants from different donors using this innovative preservation method, suggesting that 10°C storage leads to excellent outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor lungs cold preservation at 10 °C offers a potential logistic advantage in lung transplantation. Gil Barturen, M., Laporta Hernández, R., Romero Berrocal, A., et al.[2023]

Using glutathione (GSH) during hypothermic storage of lungs for transplantation significantly reduces lung injury, such as edema and inflammation, compared to traditional storage solutions, as shown in a study with mongrel dogs undergoing single-lung autotransplantation after 5-6 hours of preservation.

Despite the protective effects of GSH, the study indicates that the injury mechanisms differ between the transplanted lung and the nontransplanted lung, suggesting that while GSH helps, it does not completely prevent damage from the pulmonary reimplantation response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of injury in transplanted and nontransplanted lungs after 6 h of cold storage with glutathione. Bryan, CL., Patefield, AJ., Cohen, D., et al.[2017]

Pulmonary transplantation has become a successful treatment for end-stage lung disease, with current preservation techniques allowing for donor lungs to be safely stored for up to 6 hours before transplantation.

Recent advancements in lung preservation research, such as the use of colloid-based perfusates and free radical scavengers, show promise in extending the safe ischemia period and improving lung quality, potentially leading to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung preservation: a review of current practice and future directions. Kirk, AJ., Colquhoun, IW., Dark, JH.[2019]

In a study involving 18 pigs, lungs preserved solely by hypothermic storage for 18 hours showed functional recovery comparable to sham-operated controls, indicating effective preservation without the need for flushing.

Lungs that were only cooled (hypothermia alone) outperformed those that were flushed with preservation solution, suggesting that hypothermic storage may be a superior method for lung preservation in transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypothermic storage alone in lung preservation for transplantation: a metabolic, light microscopic, and functional analysis after 18 hours of preservation. Müller, C., Hoffmann, H., Bittmann, I., et al.[2019]

Ex-vivo lung perfusion is gaining acceptance as a method to extend the travel distance for donor lungs and reassess marginal donor lungs, potentially improving transplant outcomes.

Research is underway to evaluate the effectiveness of normothermic regional perfusion and to reassess the optimal temperature for static cold storage, with preliminary studies suggesting that warmer storage temperatures may allow for overnight lung storage before transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung preservation: from perfusion to temperature. Bromberger, B., Brzezinski, M., Kukreja, J.[2023]

The study found that flushing rat lungs at room temperature (F(Rt)) and storing them inflated on melting ice (S(ice)) resulted in significantly better lung graft function after transplantation, indicated by higher oxygen levels and lower injury markers compared to flushing at 4 °C.

Storage at 10 °C did not enhance lung preservation, suggesting that the combination of room temperature flushing and ice storage is optimal for reducing ischaemia-reperfusion injury in lung transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flush at room temperature followed by storage on ice creates the best lung graft preservation in rats. Munneke, AJ., Rakhorst, G., Petersen, AH., et al.[2013]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39817344/

Prolonged Preservation of up to 24 Hours at 10 °C Does ...

Prolonged static preservation of donor lungs at 10°C for up to 24 hours is safe and does not impair short-intermediate outcomes after lung transplantation.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05898776

NCT05898776 | 10°C vs 4°C Lung Preservation RCT

Thus, intentional prolongation of donor lung preservation at 10°C was shown to be clinically safe and feasible.

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jhltonline.org

jhltonline.org/article/S1053-2498(24)01242-7/fulltext

Lung Transplant Outcomes After Implementation of a ...

Purpose: Recent studies suggest 10oC cold storage for extended periods of time in lung transplants may offer equivalent or better clinical outcomes and improve ...

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journals.lww.com

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Prolonged Preservation of up to 24 Hours at 10 °C Does ...

Prolonged static preservation of donor lungs at 10 °C for up to 24 hours is safe and does not impair short-intermediate outcomes after lung transplantation.

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frontierspartnerships.org

frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12310/full

The Advent of Semi-Elective Lung Transplantation ...

Donor Lungs Cold Preservation at 10 °C Offers a Potential Logistic Advantage in Lung Transplantation. Cir Esp (Engl Ed (2023) 101:283–6 ...

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jhltonline.org

jhltonline.org/article/S1053-2498(24)00077-9/fulltext

Prolonged Donor Lung Preservation of Up to 24h Using ...

Prolonged static preservation of donor lungs at 10°C for up to 24 hours seems safe and does not impair short-intermediate outcomes after lung transplantation.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0300289624000814

Donor Lung Preservation at 10 °C: Clinical and Logistical ...

Cold static donor lung preservation at 10 °C appears to be a promising method to safely extend the cold ischemic time (CIT) and improve lung transplant (LTx) ...