NCT06327945 Transplanting Lungs From Uncontrolled Donation After Circulatory Death
| NCT ID | NCT06327945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Lung Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-01-24 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-01-24 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation.
Eligibility 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)
Contact & Investigator
Stephen Wall, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06327945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06327945 currently recruiting?
Yes, NCT06327945 is actively recruiting participants. Contact the research team at Carolyn.Sidoti@nyulangone.org for enrollment information.
Where is the NCT06327945 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06327945 clinical trial?
NCT06327945 is sponsored by NYU Langone Health. The principal investigator is Stephen Wall, MD at NYU Langone Health. The trial plans to enroll 24 participants.