International EXPAND Lung Pivotal Trial

Completed · Not applicable

Conditions studied: Lung Transplant

In brief

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.

Key facts

Study ID: NCT01963780
Run by: TransMedics
People needed: 79
Starts: 2013-11-01
Expected to finish: 2018-04-01
Last updated by the study team: 2022-07-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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