Clinical trial NCT05074160: OCS Liver Perfusion (OLP) Post-Approval Registry
Official title: OCS Liver Perfusion (OLP) Post-Approval Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2021-10-12
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants in the OLP Registry will be all adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating Registry centers.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Survival
timeFrame: 1 year post-Liver transplant
Secondary outcomes:
Other outcomes:
measure: Safety Endpoint
timeFrame: 6 months post-Liver transplant
measure: Long Term Patient Survival
timeFrame: 2 years post-transplant
measure: Long Term Graft Survival
timeFrame: 2 years post-transplant
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Atlanta
country: United States
facility: Emory
state: Georgia
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: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
References: