International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
- Conditions
- Lung Preservation
- Interventions
- Device: OCS LungDevice: Cold flush and storage
- Registration Number
- NCT01630434
- Lead Sponsor
- TransMedics
- Brief Summary
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- Registered primary double-lung transplant candidate
- Age > or equal to 18
- Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Multiple organ transplant recipient
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCS Lung (Treatment Group) OCS Lung The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. Cold flush and storage (Control Group) Cold flush and storage Donor lungs will be preserved using cold flush and storage (control group)
- Primary Outcome Measures
Name Time Method A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation. Day 30 after transplantation This composite is a single outcome measure. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
- Secondary Outcome Measures
Name Time Method Patient Survival at Day 30 Day 30 Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation 72 hours after transplantation Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation 72 hours after transplantation Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
Trial Locations
- Locations (21)
University of California at San Francisco
🇺🇸San Francisco, California, United States
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Hospitals Leuven
🇧🇪Leuven, Belgium
Universitäres Herzzentrum Hamburg GmbH
🇩🇪Hamburg, Germany
University of Padua
🇮🇹Padua, Italy
N.H.C Hospital Civil
🇫🇷Strasbourg, France
Indiana University
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Groupe Hospitalier Hopitaux Universitaries
🇫🇷Paris, France
University Hospitals of Marseille
🇫🇷Marseille, France
German Heart Institute Berlin
🇩🇪Berlin, Germany
Harefield Hospital
🇬🇧Middlesex, United Kingdom
Hannover Medical School
🇩🇪Hannover, Germany
Papworth Hospital
🇬🇧Cambridge, United Kingdom
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University Puerta de Hierro Hospital
🇪🇸Madrid, Spain
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States