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

Not Applicable

Completed

• Conditions: Liver Transplantation; Liver Preservation for Transplant

• Registration Number: NCT02522871
• Lead Sponsor: TransMedics

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Study Start: 2016-01-24
• Primary Completion: 2019-10-22
• Study Completion: 2021-11-05
• Status Verified: 2022-01
• Results First Submitted: 2022-12-12
• Results First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Results First Posted: 2023-06-29
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participants With Early Liver Allograft Dysfunction (EAD)	7 days	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)
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient	30 days	Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.

Secondary Outcome Measures

Name	Time	Method
Patient Survival at Day 30 After Transplant	30 days after transplant	Patient survival at day 30 after transplantation
Patient Survival at Initial Hospital Discharge Post Liver Transplant	at initial hospital discharge post liver transplant, an average of 11 days	Patient survival at initial hospital discharge post liver transplantation

Trial Locations

Locations (20)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Scripps; 🇺🇸 San Diego, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Tampa General; 🇺🇸 Tampa, Florida, United States

Emory; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

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