Clinical trial NCT04186221: OCS Liver PROTECT Continued Access Protocol
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-arm, continued access protocol
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Participants With Early Liver Allograft Dysfunction (EAD)
timeFrame: 7 days
Secondary outcomes:
measure: Patient Survival at Day 30 After Transplant
timeFrame: 30 days after transplant
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Tampa
country: United States
facility: Tampa General
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Einstein Center for Transplantation
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwest
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: TransMedics
name: Ahmed Elbetanony, MD
role: STUDY_DIRECTOR
References:
citation: Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.