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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OCS Liver System 		OCS Liver System
  • Device: OCS™ Liver System
Other
Control 		Standard of care (ice)
  • Other: Control

More Details

Status
Completed
Sponsor
TransMedics

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.