OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation (PROTECT)
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ClinicalTrials.gov Identifier: NCT02522871
Recruitment Status : Unknown
Verified January 2020 by TransMedics. Recruitment status was: Active, not recruiting
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Condition or disease
Liver TransplantationLiver Preservation for Transplant
Device: OCS™ Liver SystemOther: Control
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Dependent on > 1 IV inotrope to maintain hemodynamics