NCT06916325

Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion

DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: XVIVO Perfusion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant Surgery
• Liver Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-01-01
• Completion: 2032-01-01
• First posted: 2025-04-08
• Last updated: 2025-04-08

Regulatory

• FDA-regulated device study