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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
NYU Langone Health
New York, New York, United States
RECRUITINGIncidence of Primary Graft Dysfunction (PDG) Grade III
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.
Time frame: 72 Hours Post-Transplant
Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)
Time frame: 72 Hours Post-Transplant
Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)
Time frame: 1 Year Post-Transplant
Incidence of Re-Transplantation
Time frame: 1 Year Post-Transplant
Overall Survival
Time from transplant to death due to any cause.
Time frame: 72 Hours Post-Transplant
Overall Survival
Time from transplant to death due to any cause.
Time frame: 1 Year Post-Transplant
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