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NCT06327945NARecruiting

Transplanting Lungs From Uncontrolled Donation After Circulatory Death

NYU Langone Health

Start Date

1/24/2025

Completion Date

6/30/2028

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

Age Range: 18 years to No maximum

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)

Interventions

DEVICE

Lung uDCD Protocol

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Conditions

Lung Transplantation

Locations

NYU Langone Health

New York, New York 10016

United States