Evaluation of the Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP) in Patients with End-Stage Liver Disease

Status: closed to accrual and intervention

This clinical trial studies the viability and safety of using marginal livers after the liver has undergone normothermic machine perfusion (NMP) in patients with end-stage liver disease. Marginal livers, also called extended criteria donors (ECD) or “high risk” livers are initially declined for transplant. Liver transplantation is the only effective treatment for many patients with end-stage liver disease (ESLD) however; there is a shortage of available liver organs for transplant. This poses a serious risk for patients with liver failure and many patients die while waiting for a suitable donor organ. Discarded livers are livers donated from deceased individuals after brain or circulatory death, which have been offered out by the Organ Procurement Organization (OPO) according to United Network of Sharing (UNOS) rules and declined by all centers (including Barnes-Jewish Hospital) for transplantation. The normothermic machine perfusion involves storing (preserving) the liver (outside the body) at normal body temperature after it has been removed from the donor and prior to transplantation. This is done using the OrganOx metra (registered trademark) device. The device works by using a closed system connected to a mechanical pump. The pump circulates donated blood through the liver, maintaining the blood at normal body temperature, and providing oxygen and nutrition as well as a number of medications to the liver prior to transplant. The OrganOx Metra allows the function of the liver to be monitored during the period of preservation/storage. Using the NMP for the transplantation of discarded livers may increase the number of liver transplants in patients with end-stage liver disease.

Inclusion Criteria

PRE-NMP DECLINED LIVER INCLUSION
The OPO offers a declined liver with reason for decline documented along with one or more of the following criteria
Donation after circulatory death (DCD) donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) in DCD donors less than 40 minutes
DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) less than 15 minutes
Donation after brain death (DBD) donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with less than 8 hours cold ischemia time and DCD livers with less than 7 hours cold ischemia time (defined as the interim from initiation of donor in vivo cold organ preservation to removal of the liver graft from cold storage)
'Rapid Recovery' donors for liver procurement, meeting the above criteria
Suboptimal in situ flush
LIVER TRANSPLANTATION HUMAN INCLUSION
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
Subject, or a legally authorized representative, has given informed consent to participate in the study
Subject has a frailty classification of “mild frailty/no frailty (robust)”, based on the Liver Frailty Index (LFI), which has been assessed within 6 months prior to liver transplant OR Subject is able to perform > 350 m on a 6 minute walk test (6MWT) within 6 months prior to liver transplant. * In all cases, the “most recent” (and within 6 months prior to transplant) measurement of LFI or 6MWT will be used to determine eligibility

Exclusion Criteria

PRE-NMP DECLINED LIVER EXCLUSION
DBD or DCD donor less than 6 years old
DCD grafts with donor functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) greater than or equal to 40 minutes
DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) greater than or equal to 15 minutes
DBD livers with cold ischemia time greater than or equal to 8 hours and DCD livers with greater than or equal to 7 hours cold ischemia time
Donor serum bilirubin greater than or equal to 5 mg/dL
Liver weight less than 1 kg or greater than or equal to 3.5 kg
Grafts from patients with human immunodeficiency virus (HIV) infection
Cirrhotic livers
Livers with bridging fibrosis
LIVER TRANSPLANTATION HUMAN EXCLUSION
Subject is currently listed as a UNOS status 1A
Subject is planned to undergo simultaneous solid organ transplant
Subject is pregnant at the time of transplant
Subject Model for End Stage Liver Disease (MELD) score 29 or higher
Subject receives re-transplantation of liver

PRIMARY OBJECTIVE:

I. To successfully transplant NMP-treated livers to patients.

SECONDARY OBJECTIVES:

I. To assess liver graft function and survival after transplantation.

II. To assess morbidity associated with receipt of NMP-treated liver.

III. To evaluate the effect of liver transplantation on patient’s quality of life.

IV. To estimate the proportion of declined livers that can be used for transplantation following NMP.

OUTLINE:

Patients undergo liver transplantation with livers that receive NMP using the OrganOx Metra device on study. Patients' donor livers undergo tissue biopsy on study.

After completion of study intervention, patients are followed up at 3, 6, and 12 months.

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Evaluation of the Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP) in Patients with End-Stage Liver Disease

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