OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation

Study Overview
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Brief Summary
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A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Detailed Description
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The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

Official Title
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International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)

Conditions
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Liver Transplantation, Liver Preservation for Transplant

Intervention / Treatment
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* Device: OCS™ Liver System
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered male or female primary Liver transplant candidate Age ≥18 years old 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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS Liver System<br>OCS Liver System | Device: OCS™ Liver System<br> <br> |
| Other: Control<br>Standard of care (ice) | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Early Liver Allograft Dysfunction (EAD) | Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level > 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes) | 7 days | 
| Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient | Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival at Day 30 After Transplant | Patient survival at day 30 after transplantation | 30 days after transplant | 
| Patient Survival at Initial Hospital Discharge Post Liver Transplant | Patient survival at initial hospital discharge post liver transplantation | at initial hospital discharge post liver transplant, an average of 11 days |