Pulmonary Disease
Conditions
Brief summary
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.
Interventions
PROCEDUREDelayed Lung Transplantation
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 (MYTEMP™65HC, Benchmark Scientific).
PROCEDUREConventional Lung Transplantation
Reference Therapy
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipient is ≥ 18 years old * Recipient, or their Legally Authorized Representative is able and willing to sign informed consent * Recipient meets standard listing criteria for lung transplantation
Exclusion criteria
* Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP) * Recipient is \< 18 years old * Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation * Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant | 72 hours | As defined by International Society of Heart and Lung Transplantation (ISHLT) |
Countries
United States
Outcome results
None listed