Transplanting lungs from donors after circulatory death
Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial
This study is testing a new way to use lungs from donors who have died to see if they can be safely preserved and successfully transplanted into patients who need them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06327945 on ClinicalTrials.gov |
What this trial studies
This study evaluates a protocol for transplanting lungs from uncontrolled donors after circulatory death (uDCD). It involves preserving lungs for over three hours post-death using positive end-expiratory pressure (PEEP) and supplemental oxygen. The safety of the uDCD program will be assessed through continuous review of clinical records and operational data, focusing on lung preservation rates, recovery, and transplantation outcomes. Viability assessments will include macroscopic evaluations, radiology, and bronchoscopy prior to ex-vivo lung perfusion (EVLP). The study aims to achieve a transplantation rate of approximately 50% for lungs assessed with EVLP.
Who should consider this trial
Good fit: Ideal candidates for this study are patients currently waiting for lung transplants who are willing to participate.
Not a fit: Patients who cannot be followed for one year post-transplantation or cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the availability of donor lungs for transplantation, improving outcomes for patients with severe lung disease.
How similar studies have performed: Other studies have explored similar protocols for lung transplantation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients waiting for lung transplants * Willing to participate in the research study 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)
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Wall, MD — NYU Langone Health
- Study coordinator: Carolyn Sidoti
- Email: Carolyn.Sidoti@nyulangone.org
- Phone: 646-987-1371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.