Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Not Applicable

Recruiting

• Conditions: Lung Transplantation
• Interventions: Device: Lung uDCD Protocol

• Registration Number: NCT06327945
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-25
• Study Start: 2025-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung uDCD Protocol	Lung uDCD Protocol	-

Primary Outcome Measures

Name	Time	Method
Incidence of Primary Graft Dysfunction (PDG) Grade III	72 Hours Post-Transplant	PGD is measured 72 hours after transplantation and defined according to the International Society for Heart and Lung Transplantation (ISHLT) criteria: partial pressure of arterial oxygen divided by the fraction of inspired oxygen (Pa02/FI02) \< 200 mm Hg.

Secondary Outcome Measures

Name	Time	Method
Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)	1 Year Post-Transplant
Incidence of Re-Transplantation	1 Year Post-Transplant
Overall Survival	1 Year Post-Transplant	Time from transplant to death due to any cause.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States