Lung Preservation for Lung Transplant

Overseen By Jessica Cobb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Re-transplantation, Multi-organ transplantation

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10C cold static preservation upon organ arrival to our hospital using a specific refrigerator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Preserving of Donor Lungs, Static Cold Storage (SCS) at 10°C, Cold Static Preservation at 10°C?

Research suggests that storing donor lungs at 10°C can improve transplant logistics by extending the time the lungs can be preserved, with excellent outcomes. This method has been shown to be an optimal strategy for up to 24-36 hours of preservation. ^{1 2 3 4 5}

Is lung preservation at 10°C safe for humans?

Research suggests that preserving donor lungs at 10°C is a promising method with good outcomes, potentially improving logistics for lung transplants. While specific safety data for humans is limited, the method has been used successfully in lung transplants, indicating it is generally safe. ^{1 2 3 4 6}

How is the treatment of donor lungs at 10°C different from other lung preservation methods?

The treatment of donor lungs at 10°C is unique because it allows for longer preservation times, potentially improving logistics for lung transplants. Unlike traditional methods that use colder temperatures, this approach maintains the lungs at a slightly higher temperature, which can extend the time they remain viable for transplantation. ^{1 2 3 4 5}

Research Team

Mindaugas Rackauskas, MD, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for patients who need a lung transplant and have given informed consent. It's open to those receiving their first lung transplant from donors under 70 years old. However, it excludes anyone needing multiple organ transplants or re-transplantation, as well as cases where the donor is over 70 or there are concerns with how the lungs are preserved.

Inclusion Criteria

I am a donor under 70 years old.

I have had a lung transplant.

Informed consent provided

Exclusion Criteria

I am not older than 70 years.

I am interested in treatments that save my organs.

I am undergoing or have undergone an organ transplant again.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation Procedure

Transplant procedure with lungs preserved at 10C cold static preservation. The procedure is scheduled to start between 6:00-8:00am if donor cross clamp time is between 6pm and 4am.

12 hours

Follow-up

Participants are monitored for safety and effectiveness after the transplantation procedure

4 weeks

Treatment Details

Interventions

• Preserving of Donor Lungs

Trial Overview The study tests a method of preserving donor lungs when they're available overnight (between 6pm-4am). The procedure can be delayed until after 6am using cold static preservation at our hospital for up to 12 hours between removal from the donor and starting anesthesia on the recipient.

Participant Groups

Group I: Interventional arm Experimental Treatment 1 Intervention

During our study period, transplants with a planned recipient anesthesia starting time between 10:00pm-6:00am will be allowed to move to a 6:00-8:00am start at the earliest. To be eligible, donor lungs cross clamp time have to occur between 6pm and 4am and lungs need to be suitable for transplantation without the need for ex vivo lung evaluation. Lungs meeting criteria for direct transplantation will be transported in the usual fashion in a cooler of ice at 4oC and upon arrival to Shands UF Health they will immediately be transferred to cold static preservation at 10oC within a specific refrigerator placed in the Shands UF Health OR. The maximum preservation time from donor cold flush (cross clamp) to recipient anesthesia start should be 12 hours and the recipient procedure should not start before 6am.

Group II: Retrospective arm Active Control 1 Intervention

Outcomes will be compared to conventional transplant patients matched by age, medical diagnosis, BMI, lung allocation score and donor type ( DCD vs. NDD) using a 1:2 matching.

Preserving of Donor Lungs is already approved in United States, European Union for the following indications:

Approved in United States as Static Cold Storage (SCS) at 10°C for:

• Lung transplantation for various lung diseases

Approved in European Union as Cold Static Preservation at 10°C for:

• Lung transplantation for various lung diseases

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

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]

Combining cold static preservation (CSP) at 10°C with cycles of normothermic ex vivo lung perfusion (EVLP) allows for successful lung preservation for up to 3 days, leading to stable lung function post-transplant, as shown in a study with Yorkshire pigs.

In contrast, lungs preserved solely by continuous CSP at 10°C for 72 hours failed, highlighting the critical role of EVLP in revitalizing lung tissues and improving transplant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful 3-day lung preservation using a cyclic normothermic ex vivo lung perfusion strategy. Ali, A., Nykanen, AI., Beroncal, E., 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]

The study demonstrated that continuous perfusion of lungs during cold storage significantly reduces ischemic damage compared to traditional cold storage, as shown by fewer ischemic alterations in histopathological examinations of the lungs from rabbits.

Lungs preserved with continuous perfusion maintained better oxygen levels during auto-transplantation, suggesting that this technique may enhance lung preservation and function compared to standard cold storage methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung transplantation by continuous perfusion in an experimental auto-transplant animal model. Divisi, D., Montagna, P., Jegaden, O., et al.[2013]

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]

References

1. England 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Successful 3-day lung preservation using a cyclic normothermic ex vivo lung perfusion strategy. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Donor lungs cold preservation at 10 °C offers a potential logistic advantage in lung transplantation. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Lung transplantation by continuous perfusion in an experimental auto-transplant animal model. [2013]

5. United States 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Lung preservation: from perfusion to temperature. [2023]