OCS Liver PROTECT Continued Access Protocol

Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

Study Overview

• Status: Completed
• Conditions: Liver Transplant
• Intervention / Treatment: Device: OCS Liver System

Detailed Description

A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:

1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)

A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.

All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • La Jolla, California, United States, 92037
      • Scripps
    • San Francisco, California, United States, 94143
      • UCSF
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General
  • 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
  • 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 Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • 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 Hospital
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Health System

Participation Criteria

Eligibility Criteria

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

Description

Recipient Inclusion Criteria:

• Registered primary liver transplant candidate, male or female
• Age ≥ 18 years
• 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

Donor Inclusion Criteria

• Donor age ≥ 40 years, or
• Expected cross-clamp time ≥ 6 hours, or
• Donor after circulatory death (DCD) with age ≤ 55 years, or
• Steatotic liver > 0% and ≤ 40% macrosteatosis at time of retrieval

Donor Exclusion Criteria

• Living donors
• Liver intended for split transplants
• Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C)
• Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
• Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm	Device: OCS Liver System; OCS Liver System for preserving and assessing donor livers for transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of EAD or primary non-function	Incidence of early allograft dysfunction or primary non-function of donor liver	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OCS donor liver assessment during perfusion	Collection of liver perfusion parameters while on OCS device	During OCS perfusion, on average 4 hours
Patient Survival at Day 30 post-transplantation	Survival	30 days
Patient Survival at initial hospital discharge post liver transplantation	Survival	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of initial post-transplant ICU stay	ICU stay	ICU days, on average 5 days
Length of initial post-transplant hospital stay	Hospital stay	Hospital days, on average 10 days
Evidence of ischemic biliary complications diagnosed at 6 and 12 months post transplant	Ischemic biliary complications	6 and 12 months
Extend to reperfusion syndrome as assessed based on the rate of decrease of lactate	Reperfusion syndrome	anhepatic phase, 30-40 minutes after hepatic artery and portal vein reperfusion, 90-120 minutes after reperfusion of the transplanted liver
Pathology sample score for liver samples	Pathology sample scoring	Procedure (Pre-retrieval, Post-OCS preservation (on average, 4 hours), post reperfusion 90-120 min after reperfusion and prior to abdominal closure)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LVR10202019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes