New Protocol for Lung Transplants

Overseen By Carolyn Sidoti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Unable to follow-up, No consent

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

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for using lungs from individuals who have passed away due to heart stoppage. The goal is to determine if these lungs can be safely used for transplants by employing a special method to maintain their health for a few hours after death. Researchers will assess how well these lungs are preserved and their success in transplantation. This trial may suit individuals currently waiting for a lung transplant and willing to participate in a study. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could expand the pool of available donor lungs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that this protocol is safe for lung transplants?

Research has shown that lungs from donors who have passed away due to heart stoppage (uncontrolled donation after circulatory death, or uDCD) can be successfully used for transplants. Studies have found that patients receiving these lungs often experience excellent long-term health outcomes, indicating that many patients do well after such transplants.

In these studies, doctors take careful steps to ensure the lungs are healthy before transplantation. They use tools like X-rays and special tests to assess the condition of the lungs. Only lungs that pass these tests are used for transplants.

While the studies show promising results, every medical procedure carries risks. In this case, doctors closely monitor the transplanted lungs to ensure proper function. The main concern is preventing primary graft dysfunction, where the new lung doesn't work well immediately after surgery, particularly within the first 72 hours.

Overall, evidence suggests that using uDCD lungs for transplants is a safe option for many patients. However, those considering joining a clinical trial should discuss any concerns with their healthcare team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new protocol for lung transplants using lungs from uncontrolled donation after circulatory death (uDCD). Unlike the standard practice of using organs from brain-dead donors, this method could significantly increase the pool of available lungs for transplant. By potentially reducing wait times and improving accessibility for patients needing lung transplants, this approach may offer a promising solution to the organ shortage crisis.

What evidence suggests that this protocol is effective for lung transplants?

Research has shown that using lungs from donors who died due to heart stoppage, without prior medical intervention, can be promising for lung transplants. This trial will evaluate the effectiveness of transplanting lungs from uncontrolled donation after circulatory death (uDCD). Studies have found that, when preserved correctly, these lungs can lead to excellent long-term results. This method increases the number of available donors by using lungs that might not have been considered before. Evidence suggests that with proper preservation techniques, these lungs can function well after transplantation. The key is ensuring the lungs pass certain tests, such as ex-vivo lung perfusion (EVLP), which checks their function before the transplant. Overall, while more information is needed, early results for this method are encouraging. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephen Wall, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients on the lung transplant waiting list who are willing to be part of a research study. They must be able to give consent themselves or through a surrogate and agree to follow-up for at least one year after receiving their transplant.

Inclusion Criteria

Willing to participate in the research study

Patients waiting for lung transplants

Exclusion Criteria

Unable to be followed for 1 year after transplantation

Unable to provide written informed consent to participate in the research (or designate a surrogate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lung Preservation and Assessment

Lungs are preserved using PEEP and supplemental oxygen, followed by viability assessments including macroscopic determination, radiology, and fiber optic bronchoscopy before initiating EVLP.

3 hours

Transplantation and Immediate Post-Transplant Monitoring

Lungs are transplanted, and primary graft dysfunction (PGD) is assessed 72 hours post-transplant.

72 hours

Follow-up

Participants are monitored for survival and other outcomes up to one year after transplantation.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Trial Overview The trial tests a new protocol for preserving lungs from donors after death without heart function, using techniques like PEEP and supplemental oxygen. It aims to see how many preserved lungs pass quality checks and can be successfully transplanted.

How Is the Trial Designed?

Group I: Lung uDCD Protocol Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A new protocol was developed to successfully procure lungs from uncontrolled donors after circulatory death, with one case resulting in a successful transplantation after ex vivo lung perfusion (EVLP).

The recipient of the transplanted lungs, a 46-year-old male with cystic fibrosis, showed good health six months post-transplant, indicating that lungs can be viable for transplantation even after an extended warm ischemia period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Transplantation of Lungs From an Uncontrolled Donor After Circulatory Death Preserved In Situ by Alveolar Recruitment Maneuvers and Assessed by Ex Vivo Lung Perfusion. Valenza, F., Citerio, G., Palleschi, A., et al.[2023]

A study analyzing lung transplants from 239 brain death donors (DBD), 29 controlled donation after circulatory death donors (cDCD), and 14 uncontrolled donation after circulatory death donors (uDCD) found no significant differences in short- and mid-term outcomes, including graft dysfunction and survival rates.

The comparable outcomes across all donor types suggest that cDCD and uDCD can be viable sources for lung transplantation, potentially increasing the availability of suitable organs for patients in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung transplantation from uncontrolled and controlled donation after circulatory death: similar outcomes to brain death donors. Campo-Cañaveral de la Cruz, JL., Crowley Carrasco, S., Tanaka, S., et al.[2022]

The increase in organ donors from circulatory death significantly expands the available donor pool for transplants.

A new simplified and safe technique for lung flushing during recovery from donors after circulatory death aims to reduce warm ischemia time, which is crucial for improving transplant outcomes and survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Lung Flush Technique During Recovery From Donors After Circulatory Death. El-Sayed Ahmed, MM., Makey, IA., Landolfo, KP., et al.[2021]

The study established a reproducible model of cardiac death in pigs, demonstrating significant deterioration in lung function post-cardiac death, with a marked decrease in oxygenation and pH levels, indicating potential challenges for organ viability.

Lung volume decreased significantly, and atelectasis (non-inflated lung tissue) increased after the cardiac death process, suggesting that the condition of lungs from uncontrolled donors after circulatory determination of death may be compromised for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deterioration of Lung Function in a Pig Model of Uncontrolled Cardiac Death. Safaee Fakhr, B., Dondossola, D., Cavenago, M., et al.[2018]

This study successfully utilized uncontrolled donation after cardiac death (uDCD) for lung transplants, with a 16.7% use rate from consented donors, indicating a promising method to address lung shortages.

No severe primary graft dysfunction occurred post-transplant, and 30-day mortality was 0%, with four out of five patients surviving beyond 650 days, demonstrating both the safety and efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial lung transplantation experience with uncontrolled donation after cardiac death in North America. Healey, A., Watanabe, Y., Mills, C., et al.[2023]

The criteria for acceptable lung donors have been broadened, allowing for transplantation from donors who may not meet the ideal standards, based on specific patient and organ risk factors.

Ex vivo lung perfusion is emerging as a promising technique to recondition lungs that would typically be deemed unsuitable for transplant, potentially increasing the number of viable donor lungs available for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Management of the Potential Lung Donor. Courtwright, A., Cantu, E.[2022]

A new preservation method for lungs from uncontrolled donation after circulatory death (uDCD) showed excellent long-term outcomes, with 1-month, 1-year, and 5-year survival rates of 100%, 87.5%, and 87.5%, respectively, based on a study of 8 lung transplants from 9 evaluated donors.

The study reported a relatively low incidence of primary graft dysfunction (PGD) grade 3 at 25%, suggesting that the proposed preservation technique is effective in maintaining lung function prior to transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excellent long-term outcome with lungs obtained from uncontrolled donation after circulatory death. Suberviola, B., Mons, R., Ballesteros, MA., et al.[2023]

By accepting marginal donors and implementing a donation after circulatory death program, we have successfully expanded the pool of available donor lungs for transplantation, addressing the increasing demand.

Our results indicate that the outcomes from using marginal donors and lungs from donation after circulatory death are comparable to those from standard donors, which supports the safety and efficacy of these expanded criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor Lung Procurement by Surgical Fellow With an Expectation of High Rate of Lung Utilisation. Smail, H., Saxena, P., Wallinder, A., et al.[2018]

This case report demonstrates that lungs from an uncontrolled donor after circulatory death can be successfully procured and transplanted, even with challenges such as inhalation injury and prolonged ischemic times.

The recipient, a 26-year-old female with cystic fibrosis, showed positive outcomes post-transplant, surviving two years without signs of rejection, indicating that careful management can lead to successful transplantation from extended-criteria donors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-criteria uncontrolled DCD donor for a fragile recipient: A case report about a challenging yet successful lung transplantation. Musso, V., Mendogni, P., Scaravilli, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10607380/

Uncontrolled Donation after Circulatory Death Only Lung ... Uncontrolled DCD (uDCD) [3] represents a potential source of lungs and, since Steen's 2001 landmark case in Sweden [4], lungs have been recovered from uDCD ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S245195962200018X

Lung transplantation following donation after circulatory ... Ballesteros, et al. Excellent long-term outcome with lungs obtained from uncontrolled donation after circulatory death. Am. J. Transplant., 19 (2019), pp ...

3. jhltopen.org jhltopen.org/article/S2950-1334(25)00169-7/fulltext

Unlocking the potential of uncontrolled DCD in lung ... Uncontrolled donation after circulatory death (uDCD) represents a promising yet underutilized approach to expanding the lung donor pool amid ...

4. jhltonline.org jhltonline.org/article/S1053-2498(19)30858-7/fulltext

Excellent Long-Term Outcome with Lungs Obtained from ... We aimed to propose a simple and effective preservation method in lungs procured for transplantation from uncontrolled donation after circulatory death ...

5. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12659/full

Lung Transplantation in Controlled Donation after Circulatory ... Clinical experience with uncontrolled DCD donors is scarce and remains limited to small case series. Controlled DCD donation, meanwhile, is the ...

6. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2023.10690/full

Lung Transplantation From Controlled and Uncontrolled ... Lung Transplantation From Controlled and Uncontrolled Donation After Circulatory Death (DCD) Donors With Long Ischemic Times Managed by Simple ...

7. archbronconeumol.org archbronconeumol.org/en-evaluation-uncontrolled-donation-after-circulatory-articulo-S0300289621001976

Evaluation of Uncontrolled Donation After Circulatory ... Excellent long-term outcome with lungs obtained from uncontrolled donation after circulatory death. Am J Transplant, 19 (2019), pp. 1195-1201. http://dx.doi ...

8. jtd.amegroups.org jtd.amegroups.org/article/view/51979/html

Donation after circulatory death donors in lung transplantation Excellent long-term outcome with lungs obtained from uncontrolled donation after circulatory death. Am J Transplant 2019;19:1195-201. [Crossref] [PubMed] ...