International EXPAND Lung Pivotal Trial



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 75
Updated:12/12/2018
Start Date:November 2013
End Date:April 2018

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International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess
donor lungs that may not meet current standard donor lung acceptance criteria for
transplantation.

The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet
current standard donor lung acceptance criteria from one or more of the following
characteristics:

- Donor PaO2/FiO2 ≤ 300 mmHg; or

- Expected ischemic time > 6 hours; or

- Donor after Cardiac Death (DCD donor); or

- Donor age ≥55 years old

Inclusion Criteria:

- At least one of the following:

- 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 moderate to severe traumatic lung injury with air and/or blood leak

- 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
We found this trial at
9
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Mauricio Villavicencio, MD
Phone: 617-726-5608
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Abbas Ardehali, MD
Phone: 310-825-5841
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Gabriel Loor, MD
Phone: 612-625-4941
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Atlanta, Georgia
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Atlanta, GA
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Leuven,
Principal Investigator: Drik Van Raemdonck, MD, PhD
Phone: 3216346823
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Leuven,
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Yoshiya Toyoda, MD
Phone: 215-707-2685
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Michael A Smith, MD
Phone: 602-406-4000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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mi
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Phoenix, AZ
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San Francisco, California 94143
Principal Investigator: Jasleen Kukreja, MD
Phone: 415-353-4145
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San Francisco, CA
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