Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation (REVIVE)

TransMedics

Status: Completed

Conditions: Liver Preservation

Treatments: Device: OCS Liver

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449694

OCS-LVR-022015

Details and patient eligibility

About

A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.

Enrollment: 25 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: written informed consent

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 (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;
• Multi-organ transplant;
• Ventilator dependent;
• Dependent on > 1 IV inotrope to maintain hemodynamics;
• Malignancy excluding HCC;
• Infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

OCS Liver

Experimental group

Description:

OCS Liver will be used to preserve the donor liver

Treatment:

Device: OCS Liver