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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants requiring liver transplant | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual hypothermic oxygenated perfusion (DHOPE) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 7 (post operative) |
| Overall graft survival | Overall graft survival | Day 180 (post operative) |
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Participant Inclusion Criteria:
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
- 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 is willing to comply with the study requirements and procedures
Participant Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaya Tiwari | Contact | 240-758-3818 | jaya.tiwari@xvivogroup.com |
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