Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Gabriel Schnickel, MD, MPH

Description

Summary

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

Official Title

International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)

Keywords

Liver Transplantation Liver Preservation for Transplant Liver Extracts OCS™ Liver System OCS Liver System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join 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

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • Scripps accepting new patients
    San Diego California 92121 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT02522871
Study Type
Interventional
Last Updated