NYU Langone Health
New York, 10016, United States
Location status: Recruiting
NCT Number: NCT06327945
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 72 Hours Post-Transplant
Time frame: 1 Year Post-Transplant
Time frame: 1 Year Post-Transplant
Time frame: 72 Hours Post-Transplant
Time from transplant to death due to any cause.
Time frame: 1 Year Post-Transplant
Time from transplant to death due to any cause.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00552357
Cardiovascular Diseases, Lung Transplantation
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT07715617
Alpha-1-antitrypsin Deficiency, Artificial Intelligence (AI)
Bron, France
View Trial DetailsNCT05837663
Lung Transplantation
Phoenix, Arizona, United States
View Trial DetailsNCT06018766
Bronchial Diseases, Bronchiolitis
San Francisco, California, United States
View Trial Details