Study Results
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View full resultsBasic Information
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TERMINATED
NA
46 participants
INTERVENTIONAL
2018-03-12
2022-07-06
Brief Summary
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Detailed Description
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At least one of the following:
* Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
* Expected cross-clamp time \> 6 hours for the second lung; or
* Donor after Cardiac Death (DCD donor); or
* Donor age ≥ 55 years old
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OCS Preservation
OCS Lung Preservation
OCS Lung Preservation
Interventions
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OCS Lung Preservation
OCS Lung Preservation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria
* Single lung recipient
* Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
* Participant in any other clinical or investigational trials/programs
18 Years
75 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 Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Nebraska
Omaha, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OCS-LUN-012017
Identifier Type: -
Identifier Source: org_study_id
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