Donor Criteria
About Trial
- Pivotal Clinical Study Protocol
- Eligibility Criteria
- Donor Criteria
Lungs are eligible for use in this study when an OPO verifies that those lungs would not otherwise be used for transplantation.
The donor lung is excluded from EVLP if at least one of the following criteria have been met:
The donor lung has confirmed pneumonia and/or persistent purulent secretions identified via bronchoscopy prior to donor lung excision.
Any purulent secretions not considered persistent identified in the donor lung prior to excision that do not clear by the hour 3 assessment of EVLP.
The donor lung has confirmed evidence of aspiration.
The donor lung has significant mechanical lung injury or trauma.
The donor has HIV or active Hepatitis C.
The CIT, starting at donor aortic cross clamp/initial flush (CIT-1), required to transport the lung from the donor site to start of the EVLP procedure at a Sponsor facility will be > 10 hrs.
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