GUARDIAN-Liver will include transplant centers across the U.S. and Europe. The primary objectives of the post-market registry study are to evaluate short term post-transplant outcomes (initial hospital admission), intermediate term outcomes (3 and 6 month follow up) and long-term outcomes (1-year follow up) in patients with transplanted donor livers that were preserved and transported within the Paragonix LIVERguard™ Donor Liver Preservation System.
There will be no changes to existing standard protocols involved in donor liver transplantation. The registry study will also further analyze the impact of a variety of donor, recipient and transport-related parameters on patient outcomes, including donor clinical backgrounds, recipient factors and total ischemic times.
