An interventional study of dual hypothermic oxygenated perfusion (DHOPE) in Liver Transplant Surgery and Liver Transplantation, sponsored by XVIVO Perfusion. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by XVIVO Perfusion · Not applicable, Interventional, and Treatment
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.
XVIVO Perfusion is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participant Inclusion Criteria:
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
Participant Exclusion Criteria:
Extended criteria donor donation after brain death (ECD-DBD) or donation after circulatory death (DCD) donor organs will be recovered, transported via static cold storage (SCS), and undergo dual hypothermic oxygenated perfusion (DHOPE) on Liver Assist.
Device: dual 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.
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
XVIVO Perfusion