Study Results
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View full resultsBasic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2020-02-03
2023-02-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
OCS Liver System
OCS Liver System for preserving and assessing donor livers for transplantation
Interventions
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OCS Liver System
OCS Liver System for preserving and assessing donor livers for transplantation
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
* 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
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmed Elbetanony, MD
Role: STUDY_DIRECTOR
TransMedics
Locations
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Scripps
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
UCSF
San Francisco, California, United States
Tampa General
Tampa, Florida, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Einstein Center for Transplantation
The Bronx, New York, United States
Ohio State University
Columbus, Ohio, United States
Methodist University Hospital
Memphis, Tennessee, United States
University of Texas Southwest
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OCS-LVR10202019
Identifier Type: -
Identifier Source: org_study_id
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