Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
Not Applicable
Completed
- Conditions
- Pulmonary Disease
- Registration Number
- NCT04568694
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States
NYU Langone Health🇺🇸New York, New York, United States