Clinical trial NCT02522871: OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
Official title: International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Liver Preservation for Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Detailed description: The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

Eligibility criteria: Inclusion Criteria:

* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* 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

Primary outcomes:
measure: Participants With Early Liver Allograft Dysfunction (EAD)
timeFrame: 7 days
measure: Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
timeFrame: 30 days
Secondary outcomes:
measure: Patient Survival at Day 30 After Transplant
timeFrame: 30 days after transplant
measure: Patient Survival at Initial Hospital Discharge Post Liver Transplant
timeFrame: at initial hospital discharge post liver transplant, an average of 11 days
Other outcomes:
measure: Evidence of Ischemic Biliary Complications Diagnosed at 6 Months
timeFrame: 6 months post transplant
measure: Evidence of Ischemic Biliary Complications Diagnosed at 12 Months
timeFrame: 12 months post transplant
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Scripps
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Tampa
country: United States
facility: Tampa General
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
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: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
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
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
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
state: Texas
city: San Antonio
country: United States
facility: University of Texas San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: TransMedics
name: Ahmed Elbetanony, MD
role: STUDY_DIRECTOR
References:
citation: Markmann JF, Abouljoud MS, Ghobrial RM, Bhati CS, Pelletier SJ, Lu AD, Ottmann S, Klair T, Eymard C, Roll GR, Magliocca J, Pruett TL, Reyes J, Black SM, Marsh CL, Schnickel G, Kinkhabwala M, Florman SS, Merani S, Demetris AJ, Kimura S, Rizzari M, Saharia A, Levy M, Agarwal A, Cigarroa FG, Eason JD, Syed S, Washburn WK, Parekh J, Moon J, Maskin A, Yeh H, Vagefi PA, MacConmara MP. Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant: The OCS Liver PROTECT Randomized Clinical Trial. JAMA Surg. 2022 Mar 1;157(3):189-198. doi: 10.1001/jamasurg.2021.6781.