- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194437
OCS Liver DCD Trial
January 9, 2024 updated by: TransMedics
Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
California
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La Jolla, California, United States, 92037
- Scripps
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La Jolla, California, United States, 92037
- University of San Diego
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San Francisco, California, United States, 94143
- UCSF
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Stanford, California, United States, 94305
- Stanford University
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Florida
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Tampa, Florida, United States, 33606
- Tampa General
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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New York
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Bronx, New York, United States, 10467
- Montefiore
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New York, New York, United States, 10029
- Mount Sinai Hospital
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwest
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Houston, Texas, United States, 77030
- Houston Methodist
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San Antonio, Texas, United States, 78249
- University of Texas San Antonio
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Virginia
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Richmond, Virginia, United States, 23219
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Registered primary liver transplant candidate
- Age ≥ 18 years
- Obtained informed consent
Exclusion Criteria:
- Acute, fulminant liver failure
- Prior solid organ or bone marrow transplant
- Ventilator dependent on day of transplant/donor organ offer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCS Preserved Livers
This is a single-arm trial of OCS preserved livers used for transplantation.
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The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver graft survival through 6 months post-transplant
Time Frame: 6 months
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Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of donor liver utilization after OCS liver perfusion
Time Frame: OCS liver perfusion
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The number of eligible donor livers that were instrumented and perfused on OCS liver system and successfully transplanted, divided by the number of eligible donor livers that were instrumented and perfused on OCS
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OCS liver perfusion
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Incidence of ischemic biliary cholangiopathy at 6 months post-transplant
Time Frame: 6 months
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Evaluation of ischemic biliary complications
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6 months
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Incidence of Early Allograft Dysfunction (EAD) or primary non-function
Time Frame: 7 days
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Evaluation of EAD via AST, Bilirubin and INR
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7 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient and graft survival
Time Frame: Day 30
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Survival as determined by follow-up visit/call with patient or health care provider.
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Day 30
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Patient and graft survival
Time Frame: 6 months
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Survival as determined by follow-up visit/call with patient or health care provider.
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6 months
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Patient and graft survival
Time Frame: 12 months
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Survival as determined by follow-up visit/call with patient or health care provider.
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12 months
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Patient and graft survival
Time Frame: 24 months
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Survival as determined by follow-up visit/call with patient or health care provider.
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24 months
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Patient and graft survival
Time Frame: 36 months
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Survival as determined by follow-up visit/call with patient or health care provider.
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36 months
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Patient and graft survival
Time Frame: 48 months
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Survival as determined by follow-up visit/call with patient or health care provider.
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48 months
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Patient and graft survival
Time Frame: 60 months
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Survival as determined by follow-up visit/call with patient or health care provider.
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60 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahmed Elbetanony, MD, TransMedics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2020
Primary Completion (Actual)
March 22, 2022
Study Completion (Estimated)
November 19, 2026
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
December 9, 2019
First Posted (Actual)
December 11, 2019
Study Record Updates
Last Update Posted (Estimated)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- OCS-LVR-092019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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