Liver Transplantation, Liver Transplant Surgery
Conditions
Brief summary
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.
Interventions
DEVICEdual hypothermic oxygenated perfusion (DHOPE)
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.
Sponsors
XVIVO Perfusion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant Inclusion Criteria: 1. Participant is able to provide informed consent and HIPAA authorization 2. Age ≥18 years 3. Participant is registered as an active first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list for primary liver transplantation \- For participants with hepatocellular carcinoma (HCC) as indication for Orthotopic Liver Transplantation, the tumor must be within Milan Criteria or down-staged to Milan Criteria at the time of transplant 4. Participant is willing to comply with the study requirements and procedures Participant
Exclusion criteria
1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.) 2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A) 3. Participant is listed for a repeat liver transplantation (\>1 graft) 4. Participant is pregnant 5. Participant is on respiratory (ventilator dependent) and/or cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics) 6. Participant is enrolled in an interventional clinical trial with an investigational drug or device 7. Presence of other medical, social, or psychological conditions that in the investigator's opinion, could limit the participant's ability to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall graft survival | Day 180 (post operative) | Overall graft survival |
| Incidence of Early Allograft Dysfunction | Day 7 (post operative) | 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 |
Contacts
CONTACTSarah Lowe
Outcome results
None listed