International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
NCT ID: NCT01630434
Last Updated: 2023-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2011-11-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OCS Lung (Treatment Group)
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.
OCS Lung
OCS Lung will be used to preserve the donor lungs (Treatment Group).
Cold flush and storage (Control Group)
Donor lungs will be preserved using cold flush and storage (control group)
Cold flush and storage
Donor lungs will preserved using standard cold flush and storage
Interventions
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OCS Lung
OCS Lung will be used to preserve the donor lungs (Treatment Group).
Cold flush and storage
Donor lungs will preserved using standard cold flush and storage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> or equal to 18
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria
* Single lung recipient
* Multiple organ transplant recipient
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
18 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: STUDY_DIRECTOR
Ronald Reagan Medical Center, UCLA
Dirk van Raemodonck, MD
Role: STUDY_DIRECTOR
UZ Leuven, Belgium
Gregor Warnecke, MD
Role: STUDY_DIRECTOR
Hannover Medical Center, Germany
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 at San Francisco
San Francisco, California, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Hospitals Leuven
Leuven, , Belgium
University of Alberta
Edmonton, Alberta, Canada
University Hospitals of Marseille
Marseille, , France
Groupe Hospitalier Hopitaux Universitaries
Paris, , France
N.H.C Hospital Civil
Strasbourg, , France
German Heart Institute Berlin
Berlin, , Germany
Universitäres Herzzentrum Hamburg GmbH
Hamburg, , Germany
Hannover Medical School
Hanover, , Germany
University of Padua
Padua, , Italy
University Puerta de Hierro Hospital
Madrid, , Spain
Papworth Hospital
Cambridge, , United Kingdom
Harefield Hospital
Middlesex, , United Kingdom
Countries
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References
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Warnecke G, Van Raemdonck D, Smith MA, Massard G, Kukreja J, Rea F, Loor G, De Robertis F, Nagendran J, Dhital KK, Moradiellos Diez FJ, Knosalla C, Bermudez CA, Tsui S, McCurry K, Wang IW, Deuse T, Leseche G, Thomas P, Tudorache I, Kuhn C, Avsar M, Wiegmann B, Sommer W, Neyrinck A, Schiavon M, Calabrese F, Santelmo N, Olland A, Falcoz PE, Simon AR, Varela A, Madsen JC, Hertz M, Haverich A, Ardehali A. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9.
Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27. No abstract available.
Other Identifiers
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OCS-LUN-03-2010
Identifier Type: -
Identifier Source: org_study_id
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