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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month post-transplant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am undergoing a liver transplant.
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
graft survival at 1 month post-transplant
patient survival at 1 month post-transplant
Secondary outcome measures
Estimated blood loss at transplant surgery
Hospital length of stay
ICU length of stay
+7 more

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.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,034 Previous Clinical Trials
1,365,410 Total Patients Enrolled
Cristiano Quintini, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
65 Total Patients Enrolled
Koji Hashimoto, MD, PhDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Sequential Hypo- and Normo-thermic Perfusion (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04023773 — N/A
Liver Transplant Research Study Groups: Liver perfusion
Liver Transplant Clinical Trial 2023: Sequential Hypo- and Normo-thermic Perfusion Highlights & Side Effects. Trial Name: NCT04023773 — N/A
Sequential Hypo- and Normo-thermic Perfusion (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023773 — N/A
~4 spots leftby May 2025
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