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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:January 2016
End Date:December 2020
Contact:Waleed H Hassanein, MD
Email:whassanein@transmedics.com
Phone:978-552-0901

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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.


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
We found this trial at
13
sites
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Shawn Pelletier, MD
Phone: 434-982-3665
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: James Markmann, MD
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Boston, MA
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Atlanta, Georgia
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Atlanta, GA
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Shane Ottmann, MD
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Baltimore, MD
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Columbus, Ohio 43210
Principal Investigator: Sylvester Black, MD, PhD
Phone: 614-293-4655
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Columbus, OH
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Dallas, Texas 75235
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Dallas, TX
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Marwan Abouljoud, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Houston, Texas 77030
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Houston, TX
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Trevor Reichman, MD, PhD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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San Antonio, Texas 78249
Principal Investigator: Tarunjeet S Klair, MD
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San Antonio, TX
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San Francisco, California 94143
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San Francisco, CA
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