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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02522871
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : August 6, 2018
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Liver Preservation for Transplant Device: OCS™ Liver System Other: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: OCS Liver System
OCS Liver System
Device: OCS™ Liver System
Standard of care (ice)
Other: Control

Primary Outcome Measures :
  1. Incidence of Early Liver Allograft Dysfunction (EAD) [ Time Frame: 7 days ]
  2. Incidence of liver graft related Serious Adverse Events (SAEs) [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02522871

Contact: Waleed H Hassanein, MD 978-552-0901
Contact: Tamer I Khayal, MD 978-522-0901

United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States
Contact: Garrett Roll, MD         
United States, Georgia
Emory Recruiting
Atlanta, Georgia, United States, 30322
Contact: Joseph Magliocca, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Shane Ottmann, MD         
Principal Investigator: Shane Ottmann, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: James Markmann, MD   
Principal Investigator: James Markmann, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Marwan Abouljoud, MD   
Principal Investigator: Marwan Abouljoud, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Timothy Pruett, MD         
United States, Texas
University of Texas Southwest Recruiting
Dallas, Texas, United States, 75390
Contact: Malcolm MacConmara, MD         
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Mark Ghobrial, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Igor Shumlin    434-982-3665   
Principal Investigator: Shawn Pelletier, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Trevor Reichman, MD, PhD         
Principal Investigator: Trevor Reichman, MD, PhD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators

Responsible Party: TransMedics Identifier: NCT02522871     History of Changes
Other Study ID Numbers: OCS-LVR-092014
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Liver Extracts