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OCS Liver DCD Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194437
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Condition or disease Intervention/treatment Phase
Liver Transplant Device: OCS Liver System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 24, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCS Preserved Livers
This is a single-arm trial of OCS preserved livers used for transplantation.
Device: OCS Liver System
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.




Primary Outcome Measures :
  1. Liver graft survival through 6 months post-transplant [ Time Frame: 6 months ]
    Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation


Secondary Outcome Measures :
  1. Rate of donor liver utilization after OCS liver perfusion [ Time Frame: OCS liver perfusion ]
    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

  2. Incidence of ischemic biliary cholangiopathy at 6 months post-transplant [ Time Frame: 6 months ]
    Evaluation of ischemic biliary complications

  3. Incidence of Early Allograft Dysfunction (EAD) or primary non-function [ Time Frame: 7 days ]
    Evaluation of EAD via AST, Bilirubin and INR


Other Outcome Measures:
  1. Patient and graft survival [ Time Frame: Day 30 ]
    Survival as determined by follow-up visit/call with patient or health care provider.

  2. Patient and graft survival [ Time Frame: 6 months ]
    Survival as determined by follow-up visit/call with patient or health care provider.

  3. Patient and graft survival [ Time Frame: 12 months ]
    Survival as determined by follow-up visit/call with patient or health care provider.

  4. Patient and graft survival [ Time Frame: 24 months ]
    Survival as determined by follow-up visit/call with patient or health care provider.

  5. Patient and graft survival [ Time Frame: 36 months ]
    Survival as determined by follow-up visit/call with patient or health care provider.

  6. Patient and graft survival [ Time Frame: 48 months ]
    Survival as determined by follow-up visit/call with patient or health care provider.

  7. Patient and graft survival [ Time Frame: 60 months ]
    Survival as determined by follow-up visit/call with patient or health care provider.



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 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

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): NCT04194437


Contacts
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Contact: Kelly Jork 978-494-3918 kjork@transmedics.com
Contact: Kausar Qidwai 978-494-7105 kqidwai@transmedics.com

Locations
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United States, California
Scripps Recruiting
La Jolla, California, United States, 92037
Contact: Michelle Meyer    858-554-4340    meyer.michelle@scrippshealth.org   
Principal Investigator: Christopher L Marsh, MD         
University of San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Fanny Delebecque    858-246-2144    fdelebecque@health.ucsd.edu   
Principal Investigator: Gabriel Schnickel, MD         
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Principal Investigator: Marc Melcher, MD         
United States, Florida
Tampa General Withdrawn
Tampa, Florida, United States, 33606
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    313-916-4596    ccrombe1@hfhs.org   
Contact: Iman Francis       lfranci1@hfhs.org   
Principal Investigator: Marwan Abouljoud, MD         
United States, New York
Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Omar Alani    347-671-8217    OMOHAMME@montefiore.org   
Principal Investigator: Juan Rocca, MD         
Mount Sinai Hospital 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, North Carolina
Carolinas Medical Center Not yet recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: David Levi, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Zachary Polcyn    614-366-9277    Zachary.Polcyn@osumc.edu   
Principal Investigator: Sylvester Black, MD, PhD         
United States, Texas
University of Texas Southwest Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Emily Carlson    214-648-7609    emily.carlson@utsouthwestern.edu   
Principal Investigator: Malcolm MacConmara, MD         
Houston Methodist Not yet 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
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23219
Principal Investigator: Chandra Bhati, MD         
Sponsors and Collaborators
TransMedics
Investigators
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Study Director: Ahmed Elbetanony, MD TransMedics
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT04194437    
Other Study ID Numbers: OCS-LVR-092019
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes