OCS Liver PROTECT Continued Access Protocol

Study Overview
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Brief Summary
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Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

Detailed Description
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A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics: Donor age equal to or greater than 40 years old, or Expected cross clamp time of 6 hours or greater, or Donor after circulatory death (DCD) with age less than or equal to 55 years; or Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology) A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function. All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

Official Title
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Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.

Conditions
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Liver Transplant

Intervention / Treatment
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* Device: OCS Liver System


Participation Criteria
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Eligibility Criteria
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Recipient Inclusion Criteria: Registered primary liver transplant candidate, male or female Age ≥ 18 years Signed (1) written informed consent document and (2) authorization to use and disclose protected health information Exclusion Criteria: Acute, fulminant liver failure Prior solid organ or bone marrow transplant Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of > 3 mg/dl for > 2 weeks and/or requiring hemodialysis Multi-organ transplant Ventilator dependent Dependent on > 1 IV inotrope to maintain hemodynamics Donor Inclusion Criteria Donor age ≥ 40 years, or Expected cross-clamp time ≥ 6 hours, or Donor after circulatory death (DCD) with age ≤ 55 years, or Steatotic liver > 0% and ≤ 40% macrosteatosis at time of retrieval Donor Exclusion Criteria Living donors Liver intended for split transplants Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C) Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas) Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.

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
Interventional Model Description: Prospective, single-arm, continued access protocol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br> | Device: OCS Liver System<br>* OCS Liver System for preserving and assessing donor livers for transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of EAD or primary non-function | Incidence of early allograft dysfunction or primary non-function of donor liver | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCS donor liver assessment during perfusion | Collection of liver perfusion parameters while on OCS device | During OCS perfusion, on average 4 hours | 
| Patient Survival at Day 30 post-transplantation | Survival | 30 days | 
| Patient Survival at initial hospital discharge post liver transplantation | Survival | 30 days |