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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194437
Recruitment Status : Active, not recruiting
First Posted : December 11, 2019
Last Update Posted : May 6, 2022
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)
Actual Enrollment : 9 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
Actual Primary Completion Date : March 22, 2022
Estimated Study Completion Date : November 19, 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.



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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


Locations
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United States, California
Scripps
La Jolla, California, United States, 92037
University of San Diego
La Jolla, California, United States, 92037
UCSF
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94305
United States, Florida
Tampa General
Tampa, Florida, United States, 33606
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New York
Montefiore
Bronx, New York, United States, 10467
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas Southwest
Dallas, Texas, United States, 75390
Houston Methodist
Houston, Texas, United States, 77030
University of Texas San Antonio
San Antonio, Texas, United States, 78249
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
TransMedics
Investigators
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Study Director: Ahmed Elbetanony, MD TransMedics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: May 6, 2022
Last Verified: May 2022

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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