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

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)

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Liver Preservation for Transplant
• Intervention / Treatment: Device: OCS™ Liver System; Other: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • San Diego, California, United States, 92121
      • Scripps
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Einstein Center for Transplantation
    • New York, New York, United States, 10029
      • Mount Sinai
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwest
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • San Antonio, Texas, United States, 78249
      • University of Texas San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCS Liver System	Device: OCS™ Liver System
Other: Control; Standard of care (ice)	Other: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival at Day 30 After Transplant	Patient survival at day 30 after transplantation	30 days after transplant
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: TransMedics
• Investigators: Study Director: Ahmed Elbetanony, MD, TransMedics

Publications and helpful links

General Publications

• Markmann JF, Abouljoud MS, Ghobrial RM, Bhati CS, Pelletier SJ, Lu AD, Ottmann S, Klair T, Eymard C, Roll GR, Magliocca J, Pruett TL, Reyes J, Black SM, Marsh CL, Schnickel G, Kinkhabwala M, Florman SS, Merani S, Demetris AJ, Kimura S, Rizzari M, Saharia A, Levy M, Agarwal A, Cigarroa FG, Eason JD, Syed S, Washburn WK, Parekh J, Moon J, Maskin A, Yeh H, Vagefi PA, MacConmara MP. Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant: The OCS Liver PROTECT Randomized Clinical Trial. JAMA Surg. 2022 Mar 1;157(3):189-198. doi: 10.1001/jamasurg.2021.6781.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2016
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LVR-092014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No