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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 : February 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Liver Transplantation Liver Preservation for Transplant Device: OCS™ Liver System Other: Control

Study Design

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 : October 2016
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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

Locations
United States, Georgia
Emory Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: James Markmann, MD       JMARKMANN@mgh.harvard.edu   
Principal Investigator: James Markmann, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Marwan Abouljoud, MD       MABOULJ5@hfhs.org   
Principal Investigator: Marwan Abouljoud, MD         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
United States, Texas
University of Texas Southwest Not yet recruiting
Dallas, Texas, United States, 75390
Houston Methodist Not yet recruiting
Houston, Texas, United States, 77030
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
TransMedics
More Information

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: February 12, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Liver Extracts
Hematinics