Transplanting Lungs From Uncontrolled Donation After Circulatory Death
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung uDCD Protocol.
- Who it may be relevant to
- Registry conditions: Lung Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of Primary Graft Dysfunction (PDG) Grade III [Time frame: 72 Hours Post-Transplant]
Secondary outcome measures (5)
- 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 frame: 72 Hours Post-Transplant]
- Overall Survival [Time frame: 1 Year Post-Transplant]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06327945 · 22-00009