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

Completed · Not applicable

Conditions studied: Liver Transplantation, Liver Preservation for Transplant

In brief

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

Key facts

Study ID

NCT02522871

Run by

TransMedics

People needed

300

Starts

2016-01-24

Expected to finish

2021-11-05

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Mount Sinai — New York, New York, United States
• Montefiore Einstein Center for Transplantation — The Bronx, New York, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• University of Texas Southwest — Dallas, Texas, United States
• Houston Methodist — Houston, Texas, United States
• University of Texas San Antonio — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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