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Organ Preservation

Cold Preservation vs. Machine Perfusion for Liver Transplants

N/A

Recruiting

Led By Will Chapman, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Subject must be greater than or equal to 18 years of age

Subject with end-stage liver disease who is actively listed for primary liver transplantation on the UNOS waiting list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months to 18 months

Awards & highlights

Study Summary

This trial will compare the outcomes of transplanting livers that have been kept alive with a machine after being rejected by other transplant centers, to the outcomes of using livers that have been kept cold.

Who is the study for?

This trial is for adults with end-stage liver disease who are on the UNOS waiting list for a primary liver transplant. They must be able to walk over 350 meters in six minutes or have mild/no frailty. Donors' livers, which were declined by other centers and meet specific criteria including weight and ischemia times, will be used.Check my eligibility

What is being tested?

The study compares outcomes of liver transplants using two preservation methods: standard cold storage versus Normothermic Machine Perfusion (NMP) with the OrganOx® metra device on previously discarded livers. The effectiveness of NMP-treated livers that pass viability tests will be evaluated over a year.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical risks associated with liver transplantation such as organ rejection, infection, bleeding, bile duct complications, and effects from long-term immunosuppression.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am on the UNOS waiting list for a liver transplant due to end-stage liver disease.

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The liver I am receiving is from a donor aged 6 or older, weighs 1-3.4 kg, and was preserved properly.

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The liver I might receive is from a donor aged 6 or older, weighs 1-3.4 kg, and was preserved properly.

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The time from heart stop to cold treatment start was under 15 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with no graft failure at 6 months

Total number of patients who received NMP-treated liver transplantation

Secondary outcome measures

Assess liver graft function and survival after transplantation

Assess survival after transplantation

Estimate proportion of declined livers that can be used for transplantation following NMP

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Declined liver in Normothermic Machine Perfusion (NMP)Experimental Treatment1 Intervention

The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. NMP of the donated declined liver utilizing the OrganOx® metra device. NMP involves (warm) machine perfusion with oxygenated blood at normal body temperature. During NMP, the device also allows for ongoing assessment of donor liver function and further viability assessment to help determine suitability of the organ for transplant.

Group II: Standard cold preservation of liverActive Control1 Intervention

This group will receive liver transplant using the standard method of preservation. There will be 3 comparison groups: one local comparison group and two comparison groups from the national UNOS data.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,785 Total Patients Enrolled

OrganOx Ltd.Industry Sponsor

3 Previous Clinical Trials

601 Total Patients Enrolled

Mid-America TransplantOTHER

5 Previous Clinical Trials

1,700 Total Patients Enrolled

Frequently Asked Questions

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

Is access to this research open at this moment in time?

"Affirmative. The information hosted on clinicaltrials.gov states that this medical trial, which was initially advertised on December 3rd 2020, is actively enrolling patients. A total of 25 participants are needed from a single site to complete the study."

Answered by AI

What outcomes are researchers aiming to achieve through this clinical trial?

"This clinical trial seeks to evaluate the efficacy of liver transplantation over a 6 month period. Primary outcomes include the number of patients with no graft failure at 6 months, while secondary goals measure quality of life scores using an EQ-5D-5L questionnaire and 90 day and 1 year patient/graft survival rates. Additionally, early allograft dysfunction (EAD) and primary non-function (PNF) will be assessed in order to gauge progress towards long term survivability."

Answered by AI

What is the current scale of participation for this trial?

"Affirmative. According to the clinicaltrials.gov website, this medical study is actively seeking enrolments with a start date of December 3rd 2020 and an update posted on February 16th 2022. A total of 25 participants are needed for the trial at one site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RESTORE Declined Livers Study

2020. "RESTORE Declined Livers Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04483102.

All > Liver Transplant