OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

Completed

• Conditions: Liver Transplant

• Registration Number: NCT05096754
• Lead Sponsor: TransMedics

Brief Summary

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Subjects transplanted in the OCS Liver PROTECT CAP

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft Survival	24 Months	Liver Graft Survival at 24 months post-transplant.

Trial Locations

Locations (11)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Scripps; 🇺🇸 La Jolla, California, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Mount Sinai; 🇺🇸 New York, New York, United States

University of Texas Southwest; 🇺🇸 Dallas, Texas, United States

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States