OCS Liver DCD Trial

Liver Transplant Clinical Trial

Official title:

Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04194437
• Other study ID #: OCS-LVR-092019
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 24, 2020
• Est. completion date: November 19, 2026

Study information

• Verified date: December 2023
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Description:

To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: November 19, 2026
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered primary liver transplant candidate

• Age = 18 years

• Obtained informed consent

Exclusion Criteria:

• Acute, fulminant liver failure

• Prior solid organ or bone marrow transplant

• Ventilator dependent on day of transplant/donor organ offer

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Device:
• OCS Liver System
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore	Bronx	New York
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of Texas Southwest	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Houston Methodist	Houston	Texas
United States	Scripps	La Jolla	California
United States	University of San Diego	La Jolla	California
United States	Mount Sinai Hospital	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Texas San Antonio	San Antonio	Texas
United States	UCSF	San Francisco	California
United States	Stanford University	Stanford	California
United States	Tampa General	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	Day 30
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	6 months
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	12 months
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	24 months
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	36 months
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	48 months
Other	Patient and graft survival	Survival as determined by follow-up visit/call with patient or health care provider.	60 months
Primary	Liver graft survival through 6 months post-transplant	Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation	6 months
Secondary	Rate of donor liver utilization after OCS liver perfusion	The number of eligible donor livers that were instrumented and perfused on OCS liver system and successfully transplanted, divided by the number of eligible donor livers that were instrumented and perfused on OCS	OCS liver perfusion
Secondary	Incidence of ischemic biliary cholangiopathy at 6 months post-transplant	Evaluation of ischemic biliary complications	6 months
Secondary	Incidence of Early Allograft Dysfunction (EAD) or primary non-function	Evaluation of EAD via AST, Bilirubin and INR	7 days