CompletedNot Applicable

International EXPAND Lung Pivotal Trial

United States79 participantsStarted 2013-11

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant

Timeframe: 30 days post lung transplantation

Trial details

NCT IDNCT01963780

SponsorTransMedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-22

Results submitted2022-04-06

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