OCS Liver Perfusion (OLP) Post-Approval Registry

Liver Transplant Clinical Trial

Official title:

OCS Liver Perfusion (OLP) Post-Approval Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05074160
• Other study ID #: OCSLIVER-01-PAS
• Status: Active, not recruiting
• Start date: October 14, 2021
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.

Description:

OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 166
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System

Donor Exclusion Criteria:

• Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or

• Split donor liver; or

• DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or

• DCD donors age >55 years; or

• DCD donor liver with macrosteatosis of >15%

• Living donors

• Donors with positive serology for HIV, Hep B and C

• Donors with macrosteatosis of =40%

Recipient Exclusion Criteria:

• Fulminant liver failure; or

• Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or

• Chronic renal dialysis at time of transplant; or

• Dependency on more than 1 inotropic agent to maintain hemodynamics; or

• Ventilator dependent at time of transplant.

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Device:
• OCS Liver
Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Locations

Country	Name	City	State
United States	Emory	Atlanta	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke Medical Center	Durham	North Carolina
United States	Houston Methodist	Houston	Texas
United States	University of California San Diego	La Jolla	California
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint	6-months liver graft survival post-Liver transplant	6 months post-Liver transplant
Other	Long Term Patient Survival	K-M Patient survival at 1- and 2-years post-transplant	2 years post-transplant
Other	Long Term Graft Survival	K-M Graft survival at 6 months, 1- and 2-years post-transplant	2 years post-transplant
Primary	Patient Survival	1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.	1 year post-Liver transplant