OCS™ Lung TOP Registry For Donor Lungs for Transplantation
Study Details
Study Description
Brief Summary
Single-arm, prospective, multi-center, post-approval U.S. registry
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is an all-comers registry that will enroll:
-
Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
-
Consented 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 the first 289 eligible/PAS consented 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 the first 266 eligible/PAS consented 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 both the 289 Primary Analysis Population for OCS-preserved standard criteria donor lungs and 266 Primary Analysis Population for OCS-preserved donor lungs initially deemed unacceptable have been completed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Standard Donor Lungs Primary Analysis Population The first 289 eligible/PAS consented recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. |
Device: OCS 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.
|
| Initially Unacceptable Donor Lung Primary Analysis Pop. The first 266 eligible/PAS consented recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. |
Device: OCS 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.
|
| All Other Enrolled Patients All OCS Lung transplanted patients that do not meet any of the above analysis populations. |
Device: OCS 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.
|
Outcome Measures
Primary Outcome Measures
- 12-month patient and graft survival post double-lung transplant [12 months]
Primary Effectiveness Endpoint
Secondary Outcome Measures
- 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 Outcome Measures
- 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 survival estimated at Month 1, 6, 12, 24, 36, 48 and 60 [1,6,12,24,36,48,60 months]
Survival evaluation (K-M)
- Survival incidence at Month 6, 12, 24, 36, 48 and 60 [6,12,24,36,48,60 months]
Survival incidence (simple proportion)
- 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)
- Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 12, 24, 36, 48 and 60 [12,24,36,48,60 months]
BOS Incidence (simple proportion)
- Incidence of re-transplantation (graft failure) at Month 12, 24, 36, 48 and 60 [12,24,36,48,60 months]
Graft failure
- Kaplan-Meier transplantation-free survival estimated at Month 12, 24, 36, 48 and 60 [12,24,36,48,60 months]
Graft failure
- 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
- Survival incidence at 30 days [30 days]
Safety Endpoint
- Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days. [30 days or hospital discharge (whichever is longer)]
Safety Endpoint
Eligibility Criteria
Criteria
This is an all-comers registry that will enroll all:
-
Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
-
Consented 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 the first 289 eligible/PAS consented 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 the first 266 eligible/PAS consented 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Joseph's Hospital and Medical Center | Phoenix | Arizona | United States | 85013 |
| 2 | UCLA | Los Angeles | California | United States | 90095 |
| 3 | Stanford University | Palo Alto | California | United States | 94304 |
| 4 | UCSF | San Francisco | California | United States | 94143 |
| 5 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 6 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 7 | Johns Hopkins | Baltimore | Maryland | United States | 21218 |
| 8 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 9 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 10 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 11 | Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 12 | Montefiore | Bronx | New York | United States | 10467 |
| 13 | Duke University | Durham | North Carolina | United States | 27710 |
| 14 | Temple University | Philadelphia | Pennsylvania | United States | 19140 |
| 15 | Baylor St. Luke's Medical Center | Houston | Texas | United States | 77030 |
| 16 | Houston Methodist | Houston | Texas | United States | 77030 |
| 17 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 18 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- TransMedics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OCS-LUN-PAS01