OCS Liver PROTECT Continued Access Protocol

2019-12-10 01:20:58 | BioPortfolio


Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.


A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:

1. Donor age equal to or greater than 40 years old, or

2. Expected cross clamp time of 6 hours or greater, or

3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or

4. Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)

A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.

All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

Study Design


Liver Transplant


OCS Liver System


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2019-12-10T01:20:58-0500

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