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

TransMedics

Status: Completed

Conditions: Liver Transplantation; Liver Preservation for Transplant

Treatments: Other: Control; Device: OCS™ Liver System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02522871

OCS-LVR-092014

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

OCS Liver System

Experimental group

Description:

OCS Liver System

Treatment:

Device: OCS™ Liver System

Control

Other group

Description:

Standard of care (ice)

Treatment:

Other: Control