Lung Transplantation
Conditions
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.
Interventions
DEVICEOCS Lung System
The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: * Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. * Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. * Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.
Sponsors
TransMedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This is an all-comers registry that will enroll all: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month patient and graft survival post double-lung transplant | 12 months | Primary Effectiveness Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs | 2 hours | Lung ischemic time |
| 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 - Incidence of PGD3 at 72 hours post-transplantation | 72 hours | Primary Graft Dysfunction |
| Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate | 1 hour | Utilization Rate |
| Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation | Within 72 hours post-transplantation | Primary Graft Dysfunction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lung graft-related SAEs through 30 days post-transplant or discharge - Bronchial anastomotic complications; Major pulmonary-related infection | 30 days or hospital discharge (whichever is longer) | Safety Endpoint |
| Kaplan-Meier graft survival (freedom from re-transplant/graft failure) at Month 12, 24, 36, 48 and 60 | 12,24,36,48,60 months | Graft failure |
| Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days. | 30 days or hospital discharge (whichever is longer) | Safety Endpoint |
| Survival incidence at 30 days | 30 days | Safety Endpoint |
| Standard Criteria Lungs - Incidence of PGD3 at T72 hours | 72 hours | Primary Graft Dysfunction |
| Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs | 2 hours | Ischemic and cross-clamp times |
| Kaplan-Meier patient survival estimated at Month 1, 6, 12, 24, 36, 48 and 60 | 1,6,12,24,36,48,60 months | Survival evaluation (K-M) |
| Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60 | 12,24,36,48,60 months | BOS free survival (K-M) |
| Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60 | 12,24,36,48,60 months | Freedom from BOS (K-M) |
Countries
United States
Outcome results
None listed