Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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

Qualifiers

Patients waiting for lung transplants

Willing to participate in the research study

Disqualifiers

Unable to be followed for 1 year after transplantation

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

Trial design

Treatments tested in this trial

  • Lung uDCD Protocol

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

NYU Langone Health

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator