OCS Liver PROTECT Continued Access Protocol

Completed · Not applicable

Conditions studied: Liver Transplant

In brief

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

Key facts

Study ID

NCT04186221

Run by

TransMedics

People needed

74

Starts

2020-02-03

Expected to finish

2023-02-02

Last updated by the study team

2024-07-24

Who can join

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

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
• 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.

Where it is running

• Scripps — La Jolla, California, United States
• University of California San Diego — La Jolla, California, United States
• UCSF — San Francisco, California, United States
• Tampa General — Tampa, Florida, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Mount Sinai Hospital — New York, New York, United States
• Montefiore Einstein Center for Transplantation — The Bronx, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• University of Texas Southwest — Dallas, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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