OCS™ Lung TOP Registry For Donor Lungs for Transplantation
- Conditions
- Lung Transplantation
- Interventions
- Device: OCS Lung System
- Registration Number
- NCT03639025
- Lead Sponsor
- TransMedics
- Brief Summary
Single-arm, prospective, multi-center, post-approval U.S. registry
- Detailed Description
This is an all-comers registry that will enroll:
1. Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
2. Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
3. All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
1. TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
2. TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
3. All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 458
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard Donor Lungs Primary Analysis Population OCS Lung System Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. All Other Enrolled Patients OCS Lung System All OCS Lung transplanted patients that do not meet any of the above analysis populations. Donor Lungs Initially Unacceptable Primary Analysis Pop. OCS Lung System Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- Primary Outcome Measures
Name Time Method 12-month patient and graft survival post double-lung transplant 12 months Primary Effectiveness Endpoint
- Secondary Outcome Measures
Name Time Method Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation 72 hours Primary Graft Dysfunction
Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs 2 hours Lung ischemic time
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation Within 72 hours post-transplantation Primary Graft Dysfunction
Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours) 0, 24, 48 and 72 hours Primary Graft Dysfunction
Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate 1 hour Utilization Rate
Trial Locations
- Locations (18)
Houston Methodist
🇺🇸Houston, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
UCLA
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
UCSF
🇺🇸San Francisco, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Emory
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University
🇺🇸Durham, North Carolina, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States