Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXVIVO Perfusion
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is able to provide informed consent and HIPAA authorization
Age ≥18 years
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
Participant is willing to comply with the study requirements and procedures
Disqualifiers
Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)
Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)
Participant is listed for a repeat liver transplantation (>1 graft)
Participant is pregnant
Trial design
Design model
Single group
Treatments tested in this trial
dual hypothermic oxygenated perfusion (DHOPE)
DeviceClinically, 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.
Treatment groups
215 Participants
are divided into 1 treatment groupGroup A: Participants requiring liver transplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
Overall graft survival
Overall graft survival
Time frame
Day 180 (post operative)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: