NCT06327945

Transplanting Lungs From Uncontrolled Donation After Circulatory Death

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Transplantation

Interventions

Type	Name	Description
DEVICE	Lung uDCD Protocol	The intervention is initiation of PEEP and supplemental oxygen, without requiring prior permission (e.g., for cases not having first person authorization for organ donation and organ donation for research), to offer lung donation opportunities for cases which would otherwise be ineligible in the U.S.

Timeline

• Start date: 2025-01-24
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2024-03-25
• Last updated: 2025-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study