WP02 Continued Access Study

Study Overview
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Brief Summary
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The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.

Official Title
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Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation

Conditions
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Liver Transplantation

Intervention / Treatment
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* Device: Normothermic Machine Perfusion (NMP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or greater Subject is registered as an active recipient on the UNOS waiting list for liver transplantation Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization Subject is able and willing to comply with all study requirements Exclusion Criteria: Subject requiring all of the following at the time of transplantation: Oxygen therapy via a ventilator/respirator Inotropic support Renal replacement therapy Subject has acute/fulminant liver failure (UNOS status 1A) Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney) Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normothermic Machine Perfusion (NMP)<br>Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use. | Device: Normothermic Machine Perfusion (NMP)<br>* Storage and transportation of the donated liver using the OrganOx metra device.<br>* Other names: OrganOx metra device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Early Allograft Dysfunction (EAD) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Primary Non-function |  | 10 days | 
| Measure Graft Survival |  | 6 months | 
| Measure Subject Survival |  | 6 months | 
| Measure Post-reperfusion Syndrome Via Mean Arterial Pressure (MAP) |  | 1 day | 
| Measure Biochemical Liver Function Via Bilirubin (mg/dL) |  | 6 months | 
| Measure Biochemical Liver Function Via GGT (IU/L) |  | 6 months | 
| Measure Biochemical Liver Function Via ALT (IU/L) |  | 6 months | 
| Measure Biochemical Liver Function Via AST (IU/L) |  | 6 months | 
| Measure Biochemical Liver Function Via ALP (IU/L) |  | 6 months | 
| Measure Biochemical Liver Function Via INR |  | 6 months | 
| Measure Biochemical Liver Function Via Lactate (mmol/L) |  | 6 months | 
| Incidence of Biliary Investigations/Interventions |  | 6 months | 
| Measure Incidence of Livers Placed on the Device But Not Transplanted |  | 1 day | 
| Measure Organ Utilization Via Incidence of EAD, Discard, or Primary Non-function |  | 10 days | 
| Measure Healthcare Costs |  | 6 months | 
| Measure Quality of Life Via the EQ-5D Quality of Life Index |  | 6 months | 
| Incidence of Ischemia-reperfusion Injury Via Analysis of Post-reperfusion Biopsies |  | 1 day |