OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
1 other identifier
observational
74
1 country
11
Brief Summary
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Typical duration for all trials
11 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
Study Start
First participant enrolled
February 3, 2020
CompletedFirst Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedDecember 8, 2023
May 1, 2023
3 years
October 15, 2021
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Graft Survival
Liver Graft Survival at 24 months post-transplant.
24 Months
Interventions
Transplant with an OCS preserved liver.
Eligibility Criteria
Subjects transplanted in the OCS Liver PROTECT CAP
You may qualify if:
- Subjects transplanted in the OCS Liver PROTECT CAP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (11)
Scripps
La Jolla, California, 92037, United States
University of California San Diego
La Jolla, California, 92037, United States
University of California San Francisco
San Francisco, California, 94143, United States
Johns Hopkins
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Mount Sinai
New York, New York, 10029, 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
Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
October 27, 2021
Study Start
February 3, 2020
Primary Completion
February 2, 2023
Study Completion
February 2, 2023
Last Updated
December 8, 2023
Record last verified: 2023-05