Study Results
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View full resultsBasic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2013-11-30
2018-04-30
Brief Summary
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Detailed Description
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* Donor PaO2/FiO2 ≤ 300 mmHg; or
* Expected ischemic time \> 6 hours; 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 Lung Tx.
A prospective, pivotal single arm trial.
OCS Lung Preservation
Interventions
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OCS Lung Preservation
Eligibility Criteria
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Inclusion Criteria
* Donor PaO2/FiO2 ≤ 300 mmHg; or
* Expected ischemic time \> 6 hours; or
* Donor after Cardiac Death (DCD donor); or
* Donor age ≥55 years old
Exclusion Criteria
* Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
* Previous history of pulmonary disease
* Multiple transfusions of \>10 pRBCs units
* ABO incompatibility
* Tobacco history of \>20 pack years
18 Years
75 Years
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Principal Investigators
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Abbas Ardehali, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Dirk Van Raemdonck, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Leuven Medical Center
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California at Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Emory
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Duke University
Durham, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Leuven Hospital
Leuven, , Belgium
Hannover Medical School
Hanover, , Germany
Hospital Universitario Puerta De Hierro
Madrid, , Spain
Countries
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References
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Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1.
Other Identifiers
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OCS-LUN-012013
Identifier Type: -
Identifier Source: org_study_id
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