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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

Must not have

Subject receives re-transplantation of liver.

Subject is requiring oxygen therapy via ventilator/respiratory support

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months to 18 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I am receiving a second liver transplant.

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I need a machine to help me breathe.

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I am listed as a top priority for organ transplant.

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My organ donor is younger than 6 years old.

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My organ donation occurred more than 15 minutes after my heart stopped.

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I am scheduled for a solid organ transplant.

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My liver has severe scarring.

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My liver transplant involves a donor liver that was preserved in cold storage for a specific time.

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My donor organ was without blood flow for 40 minutes or more before being preserved.

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My liver weight is either below 1 kg or above 3.5 kg.

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My liver is cirrhotic.

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

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

Primary study objectives

Number of patients with no graft failure at 6 months

Total number of patients who received NMP-treated liver transplantation

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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 / 16Eligibility criteria met