The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Clinically, end-ischemic DHOPE has been shown to restore hepatic ATP, reduce reperfusion injury, and improve outcomes after deceased donor liver transplantation. Recent prospective and retrospective clinical studies detail the safety and feasibility of prolonged preservation of donor livers with DHOPE for up to 20 hours; prolonged perfusion has shown similarly low rates of serious adverse events, a potential protective effect in mitigating acute kidney injury and may facilitate decreased frequency of discarded and nonuse of donor livers.
Incidence of Early Allograft Dysfunction
Incidence of Early Allograft Dysfunction (EAD) defined according to the Olthoff criteria as the presence of one or more of the following postoperative laboratory analyses observations reflective of liver injury and function: * Bilirubin ≥ 10mg/dL on postoperative day (POD) 7, or * International normalized ratio (INR) ≥ 1.6 on POD 7, or * Alanine or aspartate aminotransferases (AST and ALT) \> 2000 IU/L within the first 7 PODs
Time frame: Day 7 (post operative)
Overall graft survival
Overall graft survival
Time frame: Day 180 (post operative)
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