Summary

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

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
    La Jolla California 92037 United States
  • Scripps
    San Diego California 92121 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT02522871
Study Type
Interventional
Last Updated