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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung uDCD Protocol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung uDCD Protocol | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | 72 Hours Post-Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) | 72 Hours Post-Transplant | |
| Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) | 1 Year Post-Transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Sidoti | Contact | 646-987-1371 | Carolyn.Sidoti@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Wall, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared beginning 9 months and ending 5 years following article publication. The data will be available at a third party website. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 3 months and ending 5 years following article publication.
Anyone who wishes to access the data for any purpose will be able to access the data at a third party website.
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|
| Incidence of Re-Transplantation | 1 Year Post-Transplant |
| Overall Survival | Time from transplant to death due to any cause. | 72 Hours Post-Transplant |
| Overall Survival | Time from transplant to death due to any cause. | 1 Year Post-Transplant |