OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.
1 other identifier
interventional
74
1 country
17
Brief Summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedResults Posted
Study results publicly available
July 24, 2024
CompletedJuly 24, 2024
December 1, 2023
1 year
November 26, 2019
May 6, 2024
July 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Participants With Early Liver Allograft Dysfunction (EAD)
Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)
7 days
Secondary Outcomes (1)
Patient Survival at Day 30 After Transplant
30 days after transplant
Study Arms (1)
Treatment arm
EXPERIMENTALInterventions
OCS Liver System for preserving and assessing donor livers for transplantation
Eligibility Criteria
You may qualify if:
- Registered primary liver transplant candidate, male or female
- Age ≥ 18 years
- Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
You may not qualify if:
- 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
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (17)
Scripps
La Jolla, California, 92037, United States
University of California San Diego
La Jolla, California, 92037, United States
UCSF
San Francisco, California, 94143, United States
Tampa General
Tampa, Florida, 33606, United States
Johns Hopkins
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Montefiore Einstein Center for Transplantation
The Bronx, New York, 10467, United States
Ohio State University
Columbus, Ohio, 43210, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
University of Texas Southwest
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
Related Publications (1)
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.
PMID: 33650998DERIVED
Results Point of Contact
- Title
- Laura Damme, VP Clinical Affairs
- Organization
- TransMedics, Inc.
Study Officials
- STUDY DIRECTOR
Ahmed Elbetanony, MD
TransMedics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2019
First Posted
December 4, 2019
Study Start
February 3, 2020
Primary Completion
February 2, 2021
Study Completion
February 2, 2023
Last Updated
July 24, 2024
Results First Posted
July 24, 2024
Record last verified: 2023-12