Lung Transplantation
Conditions
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.
Interventions
DEVICELung 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) | 72 Hours Post-Transplant | — |
| Incidence of Re-Transplantation | 1 Year Post-Transplant | — |
| Overall Survival | 72 Hours Post-Transplant | Time from transplant to death due to any cause. |
Countries
United States
Contacts
Primary ContactCarolyn Sidoti
Outcome results
None listed