OCS Liver PROTECT Continued Access Protocol

Liver Transplant Clinical Trial

Official title:

Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186221
• Other study ID #: OCS-LVR10202019
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: February 2, 2023

Study information

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

Clinical Trial Summary

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

Description:

A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:

1. Donor age equal to or greater than 40 years old, or

2. Expected cross clamp time of 6 hours or greater, or

3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or

4. Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)

A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.

All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Recipient Inclusion Criteria:

• Registered primary liver transplant candidate, male or female

• Age = 18 years

• Signed (1) written informed consent document and (2) authorization to use and disclose protected health information

Exclusion Criteria:

• 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

Donor Inclusion Criteria

• Donor age = 40 years, or

• Expected cross-clamp time = 6 hours, or

• Donor after circulatory death (DCD) with age = 55 years, or

• Steatotic liver > 0% and = 40% macrosteatosis at time of retrieval

Donor Exclusion Criteria

• Living donors

• Liver intended for split transplants

• Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C)

• Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)

• Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Device:
• OCS Liver System
OCS Liver System for preserving and assessing donor livers for transplantation

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Einstein Center for Transplantation	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwest	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Houston Methodist Hospital	Houston	Texas
United States	Scripps	La Jolla	California
United States	University of California San Diego	La Jolla	California
United States	Methodist University Hospital	Memphis	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	UCSF	San Francisco	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	Length of initial post-transplant ICU stay	ICU stay	ICU days, on average 5 days
Other	Length of initial post-transplant hospital stay	Hospital stay	Hospital days, on average 10 days
Other	Evidence of ischemic biliary complications diagnosed at 6 and 12 months post transplant	Ischemic biliary complications	6 and 12 months
Other	Extend to reperfusion syndrome as assessed based on the rate of decrease of lactate	Reperfusion syndrome	anhepatic phase, 30-40 minutes after hepatic artery and portal vein reperfusion, 90-120 minutes after reperfusion of the transplanted liver
Other	Pathology sample score for liver samples	Pathology sample scoring	Procedure (Pre-retrieval, Post-OCS preservation (on average, 4 hours), post reperfusion 90-120 min after reperfusion and prior to abdominal closure)
Primary	Incidence of EAD or primary non-function	Incidence of early allograft dysfunction or primary non-function of donor liver	7 days
Secondary	OCS donor liver assessment during perfusion	Collection of liver perfusion parameters while on OCS device	During OCS perfusion, on average 4 hours
Secondary	Patient Survival at Day 30 post-transplantation	Survival	30 days
Secondary	Patient Survival at initial hospital discharge post liver transplantation	Survival	30 days