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

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ClinicalTrials.gov Identifier: NCT02522871
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
TransMedics

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

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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 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: OCS Liver System
OCS Liver System
Device: OCS™ Liver System
Control
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02522871


Contacts
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Contact: Waleed H Hassanein, MD 978-552-0901 whassanein@transmedics.com
Contact: Tamer I Khayal, MD 978-522-0901 tkhayal@transmedics.com

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Denya Arellano       daarellano@ucsd.edu   
Principal Investigator: Gabriel Schnickel, MD, MPH         
Scripps Recruiting
San Diego, California, United States, 92121
Contact: Rachelle Caco       caco.rachelle@scrippshealth.org   
Contact: Michelle Meyer       meyer.michelle@scrippshealth.org   
Principal Investigator: Christopher Marsh, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Garrett Roll, MD         
United States, Florida
Tampa General Recruiting
Tampa, Florida, United States, 33606
Contact: Ashley Bader    813-844-8437    abader@tgh.org   
Principal Investigator: Amy Lu, MD         
United States, Georgia
Emory Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ada Ghali, RN, BSN    404-712-9854    ada.ghali@emory.edu   
Principal Investigator: Joseph Magliocca, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sherry Leung    410-955-7518    sleung7@jhu.edu   
Principal Investigator: Shane Ottmann, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kerry Crisalli    617-643-4087    kcrisalli@mgh.harvard.edu   
Principal Investigator: James Markmann, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Catherine Crombez       ccrombe1@hfhs.org   
Contact: Iman Francis       lfranci1@hfhs.org   
Principal Investigator: Marwan Abouljoud, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ashley Roman       roman245@umn.edu   
Principal Investigator: Timothy L Pruett, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Pat Moffatt    402-552-6240    pat.moffatt@unmc.edu   
Principal Investigator: Shaheed Merani, MD         
United States, New York
Montefiore Einstein Center for Transplantation Recruiting
Bronx, New York, United States, 10467
Contact: Omar Alani    347-671-8217    omohamme@montefiore.org   
Principal Investigator: Milan Kinkhabwala, MD         
Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Brandy Haydel    212-241-0255    brandy.haydel@mountsinai.org   
Principal Investigator: Sander Florman, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Margaret Wuebker    614-293-4655    margaret.wuebker@osumc.edu   
Principal Investigator: Sylvester Black, MD, PhD         
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Talana Vogel    901-516-8823    tvogel@uthsc.edu   
Principal Investigator: Cory Eymard, MD         
United States, Texas
University of Texas Southwest Recruiting
Dallas, Texas, United States, 75390
Contact: Emily Carlson    214-648-7609    emily.carlson@utsouthwestern.edu   
Principal Investigator: Malcolm MacConmara, MD         
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Isioma Agboli, MD    281-414-9916    iagboli@houstonmethodist.org   
Principal Investigator: Ashish Saharia, MD         
University of Texas San Antonio Recruiting
San Antonio, Texas, United States, 78249
Contact: Jillian Woodworth    210-567-9229    woodworthj@uthscsa.edu   
Principal Investigator: Tarunjeet S Klair, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Jamie Nagy       JN6KM@hscmail.mcc.virginia.edu   
Principal Investigator: Shawn Pelletier, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Mary Baldecchi    804-828-7925    mary.baldecchi@vcuhealth.org   
Principal Investigator: Trevor Reichman, MD, PhD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Miriam Silva       silvacm8@uw.edu   
Principal Investigator: Jorge Reyes, MD         
Sponsors and Collaborators
TransMedics

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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT02522871     History of Changes
Other Study ID Numbers: OCS-LVR-092014
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Liver Extracts
Hematinics