Machine Perfusion for Liver Transplant Preservation

Overseen By Kevin Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Partial grafts, Incapacitated, Language barriers, Multiorgan, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

What is the purpose of this trial?

Hypothermic machine perfusion (HMP) has been shown to be beneficial to preserve extended criteria donor (ECD) livers for transplantation. Normothermic machine perfusion (NMP) had the same benefits and also the convenience on liver quality assessment. The investigators proposed to do sequential HMP (1-4 hours) and NMP (1-14 hours) on 18 ECD transplanted human livers by using an institutional-developed perfusion device for liver transplantation.

Research Team

Koji Hashimoto, MD, PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults aged 18 or older who are undergoing liver transplantation and can follow the study's procedures. They must understand and sign a consent form. It's not open to those who don't speak the language well, have mental incapacities, need multiple organ transplants, or are receiving partial grafts.

Inclusion Criteria

I am undergoing a liver transplant.

I am willing and able to follow the study's requirements.

Signed Informed Consent Form

Exclusion Criteria

I have received multiple organ transplants.

I have received a partial organ transplant.

You are not able to understand the study procedures due to language differences.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ex Vivo Organ Preservation

Liver grafts are preserved using hypothermic and normothermic machine perfusion with continuous oxygen supply

1-14 hours

Transplantation and Immediate Post-Transplant Care

Liver transplantation procedure followed by immediate post-transplant care according to clinical standards

1 month

Follow-up

Participants are monitored for safety and effectiveness after transplantation

12 months

Treatment Details

Interventions

• Sequential Hypo- and Normo-thermic Perfusion

Trial Overview The trial tests a new method of preserving donor livers using a special machine that cools them down (HMP) for 1-4 hours then warms them (NMP) for 1-14 hours before transplant. This technique aims to improve the condition of livers from donors that don't meet standard criteria.

Participant Groups

Group I: Liver perfusion Experimental Treatment 1 Intervention

Device: Liver Machine Perfusion (MP) Device The liver grafts will be preserved at hypothermic and normothermic temperature on the institutional-developed Liver MP Device, and have continuous perfusion with oxygen supply in the ex vivo organ preservation phase.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Koji Hashimoto

Lead Sponsor

Trials

1

Recruited

20+