Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gabriel Schnickel, MD, MPH
Headshot of Gabriel Schnickel
Gabriel Schnickel

Description

Summary

The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.

Details

OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Keywords

Liver Transplant OCS Liver

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System

Donor

You CAN'T join if...

  • Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
  • Split donor liver; or
  • DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
  • DCD donors age >55 years; or
  • DCD donor liver with macrosteatosis of >15%
  • Living donors
  • Donors with positive serology for HIV, Hep B and C
  • Donors with macrosteatosis of ≥40%

Recipient Exclusion Criteria:

  • Fulminant liver failure; or
  • Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
  • Chronic renal dialysis at time of transplant; or
  • Dependency on more than 1 inotropic agent to maintain hemodynamics; or
  • Ventilator dependent at time of transplant.

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Houston Methodist not yet accepting patients
    Houston Texas 77030 United States

Lead Scientist at UCSD

  • Gabriel Schnickel, MD, MPH
    Clinical Professor, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT05074160
Study Type
Observational [Patient Registry]
Participants
Expecting 160 study participants
Last Updated