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 |
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.
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
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
Leuven,
Principal Investigator: Drik Van Raemdonck, MD, PhD
Phone: 3216346823
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
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Principal Investigator: Mauricio Villavicencio, MD
Phone: 617-726-5608
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Los Angeles, California 90095
310-825-4321
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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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Minneapolis, Minnesota 55455
(612) 625-5000
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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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3401 N Broad St
Philadelphia, Pennsylvania
Philadelphia, Pennsylvania
(215) 707-2000
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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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350 W Thomas Rd
Phoenix, Arizona 85013
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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San Francisco, California 94143
Principal Investigator: Jasleen Kukreja, MD
Phone: 415-353-4145
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