Clinical trial NCT05940857: US National OCS Liver Perfusion (OLP) Registry
Official title: US National OCS Liver Perfusion (OLP) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2023-07-11
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All liver transplant recipients who are transplanted with an OCS-perfused donor liver will be enrolled in the Registry. Patients' clinical outcomes will be followed until the later of 5 years post-transplant, loss to follow-up or death.

Brief summary: This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.

TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.


Eligibility criteria: All liver transplant recipients.

Primary outcomes:
measure: Survival
timeFrame: 5 years post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital Arizona
state: Arizona
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: Jacksonville
country: United States
facility: Mayo Clinic Hospital Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Hospital Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: NY Presbyterian Hospital/Columbia Univ. Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center/Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: San Antonio
country: United States
facility: University Hospital, University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
affiliation: TransMedics
name: Ahmed Elbetanony, MD
role: STUDY_DIRECTOR
References: