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.

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

sites

Duke University

Durham, North Carolina 27710

(919) 684-8111