NCT05096741

Brief Summary

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2016

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

5.8 years

First QC Date

October 15, 2021

Last Update Submit

January 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Liver Graft Survival

    Liver Graft Survival through 2 years (24 months) after transplantation.

    2 years

Other Outcomes (1)

  • Patient Survival

    2 years

Study Arms (2)

OCS Liver

Device: OCS Liver

Control

Interventions

OCS LiverDEVICE

Transplanted with a OCS preserved liver

OCS Liver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects transplanted in the OCS Liver PROTECT Trial

You may qualify if:

  • Subjects transplanted in the OCS Liver PROTECT Trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of California San Diego

La Jolla, California, 92037, United States

Location

Scripps

San Diego, California, 92121, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Tampa General

Tampa, Florida, 33606, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38104, United States

Location

University of Texas Southwest

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 27, 2021

Study Start

January 24, 2016

Primary Completion

November 5, 2021

Study Completion

November 5, 2021

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations