N/A
N=79
International EXPAND Lung Pivotal Trial
Lung Transplant
Bottom Line
View on ClinicalTrials.gov: NCT01963780 ↗Enrolled (actual)
79
Serious AEs
77.2%
Results posted
Jul 2022
Primary outcome: Primary: 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 — 43 Participants — p=0.9663
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCS Lung Preservation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
43 | 0.9663 |
| SECONDARY Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation |
13 | — |
| SECONDARY Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours |
5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01963780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.