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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients waiting for lung transplants

• Willing to participate in the research study

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Carolyn Sidoti
Carolyn.Sidoti@nyulangone.org
646-987-1371
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 24
Treatments
Experimental: Lung uDCD Protocol
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov