OCS™ Lung TOP Registry For Donor Lungs for Transplantation
NCT ID: NCT03639025
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
458 participants
OBSERVATIONAL
2018-12-10
2029-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard Donor Lungs Primary Analysis Population
Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
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.
Donor Lungs Initially Unacceptable Primary Analysis Pop.
Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Locations
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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
Houston Methodist
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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OCS-LUN-PAS01
Identifier Type: -
Identifier Source: org_study_id
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