NCT03639025Active, not recruitingNot Applicable
The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- TransMedics
- Enrollment
- 458
- Locations
- 18
- Primary Endpoint
- 12-month patient and graft survival post double-lung transplant
Study Overview
Brief Summary
Single-arm, prospective, multi-center, post-approval U.S. registry
Detailed Description
This is an all-comers registry that will enroll:
- Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- 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.
- 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.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
12-month patient and graft survival post double-lung transplant
Time Frame: 12 months
Primary Effectiveness Endpoint
Secondary Outcomes
- Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation(72 hours)
- Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs(2 hours)
- Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation(Within 72 hours post-transplantation)
- 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)
- Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate(1 hour)
Investigators
Study Sites (18)
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