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Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial

Who can join

Ages 18 and older · All sexes

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)

About the study

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.

What is being tested

• Lung uDCD Protocol (device)

Sponsor: NYU Langone Health · Participants: 24 · Started: Jan 24, 2025

Contact the study team

• Carolyn Sidoti · Phone: 646-987-1371

Official record on ClinicalTrials.gov — NCT06327945

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.