Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Garrett Roll

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)

Details

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.

Keywords

Liver Transplantation Liver Preservation for Transplant 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 Francisco
    San Francisco California 94143 United States
  • Scripps
    San Diego California 92121 United States

Lead Scientist at UCSF

  • Garrett Roll
    Assistant Professor, Surgery. Authored (or co-authored) 61 research publications.

Details

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