OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation

Liver Transplantation Clinical Trial

— PROTECT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522871
• Other study ID #: OCS-LVR-092014
• Status: Completed
• Phase: N/A
• Start date: January 24, 2016
• Est. completion date: November 5, 2021

Study information

• Verified date: January 2022
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 5, 2021
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Liver Preservation for Transplant
• Liver Transplantation

Intervention

Device:
• OCS™ Liver System

Other:
• Control

Locations

Country	Name	City	State
United States	Emory	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Einstein Center for Transplantation	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of Texas Southwest	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Houston Methodist	Houston	Texas
United States	University of California San Diego	La Jolla	California
United States	Methodist University Hospital	Memphis	Tennessee
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mount Sinai	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Texas San Antonio	San Antonio	Texas
United States	Scripps	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Tampa General	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evidence of Ischemic Biliary Complications Diagnosed at 6 Months	Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 6 Months Follow-up Visit	6 months post transplant
Other	Evidence of Ischemic Biliary Complications Diagnosed at 12 Months	Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 12 Months Follow-up Visit	12 months post transplant
Primary	Participants With Early Liver Allograft Dysfunction (EAD)	Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level > 2000 IU/ml within the first 7 postoperative days; Bilirubin = 10 mg/dl on postoperative day 7; INR = 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)	7 days
Primary	Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient	Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.	30 days
Secondary	Patient Survival at Day 30 After Transplant	Patient survival at day 30 after transplantation	30 days after transplant
Secondary	Patient Survival at Initial Hospital Discharge Post Liver Transplant	Patient survival at initial hospital discharge post liver transplantation	at initial hospital discharge post liver transplant, an average of 11 days