Transplanting Lungs From Uncontrolled Donation After Circulatory Death

NYU Langone Health

Status: Enrolling

Conditions: Lung Transplantation

Treatments: Device: Lung uDCD Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06327945

22-00009

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Lung uDCD Protocol

Experimental group

Treatment:

Device: Lung uDCD Protocol