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Procedure

Machine Perfusion for Liver Transplant Preservation

N/A

Waitlist Available

Led By Cristiano Quintini, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing liver transplantation

Age 18 or older at the time of transplantation

Must not have

Multiorgan transplant

Recipient of partial grafts (split and living donors)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial found that sequential HMP and NMP is a feasible and effective way to preserve ECD livers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a device rather than medication, side effects may include complications related to liver transplant surgery such as infection risk increase, bleeding issues, or problems with liver function post-transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am undergoing a liver transplant.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received multiple organ transplants.

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I have received a partial organ transplant.

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I am not mentally or legally able to make my own decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

graft survival at 1 month post-transplant

patient survival at 1 month post-transplant

Secondary study objectives

Estimated blood loss at transplant surgery

Hospital length of stay

ICU length of stay

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Liver perfusionExperimental Treatment1 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.

0 / 5Eligibility criteria met