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This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Lung Transplantation | Experimental | Patients that received lung(s) delayed for transplantation |
|
| Conventional Lung Transplantation | Active Comparator | Reference Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed Lung Transplantation | Procedure | Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMPâ„¢65HC, Benchmark Scientific). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant | As defined by International Society of Heart and Lung Transplantation (ISHLT) | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nader Moazami, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | 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 upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. 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 9 months and ending 36 months following article publication
Requests may be directed to the PI.
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| Conventional Lung Transplantation | Procedure | Reference Therapy |
|