OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
PROTECT
International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
1 other identifier
interventional
300
1 country
20
Brief Summary
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
20 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
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
January 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2021
CompletedResults Posted
Study results publicly available
June 29, 2023
CompletedJune 29, 2023
January 1, 2022
3.7 years
August 11, 2015
December 12, 2022
June 12, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.
30 days
Secondary Outcomes (2)
Patient Survival at Day 30 After Transplant
30 days after transplant
Patient Survival at Initial Hospital Discharge Post Liver Transplant
at initial hospital discharge post liver transplant, an average of 11 days
Other Outcomes (2)
Evidence of Ischemic Biliary Complications Diagnosed at 6 Months
6 months post transplant
Evidence of Ischemic Biliary Complications Diagnosed at 12 Months
12 months post transplant
Study Arms (2)
OCS Liver System
EXPERIMENTALOCS Liver System
Control
OTHERStandard of care (ice)
Interventions
Eligibility Criteria
You may qualify if:
- Registered male or female primary Liver transplant candidate
- Age ≥18 years old
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (20)
University of California San Diego
La Jolla, California, 92037, United States
Scripps
San Diego, California, 92121, United States
University of California San Francisco
San Francisco, California, 94143, United States
Tampa General
Tampa, Florida, 33606, United States
Emory
Atlanta, Georgia, 30322, 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 Minnesota
Minneapolis, Minnesota, 55455, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Mount Sinai
New York, New York, 10029, United States
Montefiore Einstein Center for Transplantation
The Bronx, New York, 10467, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
University of Texas Southwest
Dallas, Texas, 75390, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Texas San Antonio
San Antonio, Texas, 78249, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Markmann JF, Abouljoud MS, Ghobrial RM, Bhati CS, Pelletier SJ, Lu AD, Ottmann S, Klair T, Eymard C, Roll GR, Magliocca J, Pruett TL, Reyes J, Black SM, Marsh CL, Schnickel G, Kinkhabwala M, Florman SS, Merani S, Demetris AJ, Kimura S, Rizzari M, Saharia A, Levy M, Agarwal A, Cigarroa FG, Eason JD, Syed S, Washburn WK, Parekh J, Moon J, Maskin A, Yeh H, Vagefi PA, MacConmara MP. Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant: The OCS Liver PROTECT Randomized Clinical Trial. JAMA Surg. 2022 Mar 1;157(3):189-198. doi: 10.1001/jamasurg.2021.6781.
PMID: 34985503DERIVED
Results Point of Contact
- Title
- Laura Damme
- Organization
- TransMedics
Study Officials
- STUDY DIRECTOR
Ahmed Elbetanony, MD
TransMedics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 13, 2015
Study Start
January 24, 2016
Primary Completion
October 22, 2019
Study Completion
November 5, 2021
Last Updated
June 29, 2023
Results First Posted
June 29, 2023
Record last verified: 2022-01