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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

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I am undergoing a liver transplant.

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I am 18 years old or older.

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,364,003 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What end goal is this research endeavor aiming to accomplish?

"This clinical trial seeks to quantify the impact of a given intervention on patient survival over one month post-transplant. Secondary objectives involve measuring Estimated Blood Loss (ml) during surgery, Graft Survival at 6 months after transplantation, and Patient Survival at 6 months following treatment."

Answered by AI

Have the enrollment procedures for this experiment yet commenced?

"This research project, which was initially published on May 1st 2021 and last modified September 20th 2022 is no longer looking for patients. Fortunately, there are 52 other studies recruiting candidates at this present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation

Koji Hashimoto 2021. "Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04023773.

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