Hypothermic Oxygenated Perfusion for Liver Transplant

Recruiting at15 trial locations

Overseen by David Reich, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bridge to Life Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a special machine that helps keep donated livers healthy before they are transplanted. It targets patients who need liver transplants and compares the new method to the usual way of preserving livers. The machine works by pumping cold, oxygen-rich fluid through the liver to maintain its condition. This new method has shown significant benefits in improving liver function before transplantation.

Research Team

David Reich, MD

Principal Investigator

Drexel University

Eligibility Criteria

This trial is for patients needing a liver transplant, where the donor's age is between 50-85 years. The donor liver must have been preserved in cold conditions for 10-15 hours and show certain levels of fat, enzymes (ALT), and bilirubin. It excludes livers not from brain-dead donors.

Inclusion Criteria

Terminal ALT 250-1500 IU/ml

My surgery involves a cold ischemia time of 10-15 hours, not counting HOPE duration.

I am between 50 and 85 years old.

Exclusion Criteria

My donor is between 18 and 85 years old.

Terminal total bilirubin >4 mg/dl

My liver transplant will be from a living donor.

Treatment Details

Interventions

• Static cold storage (Procedure)
• VitaSmart Liver Machine Perfusion System (Machine Perfusion)

Trial Overview The study compares two ways to preserve donated livers before transplantation: traditional cold storage versus using the VitaSmart Liver Machine Perfusion System followed by hypothermic oxygenated perfusion (HOPE).

Participant Groups

Group I: Static cold storage Experimental Treatment 1 Intervention

Ex-vivo donor liver preservation using static cold storage only

Group II: Hypothermic oxygenated perfusion (HOPE) Experimental Treatment 2 Interventions

Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine

Who Is Running the Clinical Trial?

Bridge to Life Ltd.

Lead Sponsor

Trials

1

Recruited

220+