Clinical trial NCT02775162: WP01 - Normothermic Liver Preservation
Official title: A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: OrganOx Ltd.
Sponsor class: INDUSTRY
Collaborators: name: North American Science Associates Ltd.
First posted: 2016-05-17
Enrollment: 267
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 multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or greater
* Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements

Exclusion Criteria:

* Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy
* Subject has acute/fulminant liver failure
* Subject undergoing simultaneous transplantation of more than one organ
* Subject is pregnant or nursing
* Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Primary outcomes:
measure: Percentage of Participants With Early Allograft Dysfunction (EAD)
timeFrame: 7 Days
Secondary outcomes:
measure: Number of Participants With Primary Non-Function
timeFrame: 10 Days
measure: Number of Participants With Graft Survival
timeFrame: 6 Months
measure: Number of Participants With Subject Survival
timeFrame: 6 Months
measure: Number of Participants With Post-Reperfusion Syndrome
timeFrame: 1 Day
measure: Measure Biochemical Liver Function Via Bilirubin
timeFrame: 6 Months
measure: Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)
timeFrame: 6 Months
measure: Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)
timeFrame: 6 Months
measure: Measure Biochemical Liver Function Via Aspartate Transaminase (AST)
timeFrame: 6 Months
measure: Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)
timeFrame: 6 Months
measure: Measure Biochemical Liver Function Via International Normalized Ratio (INR)
timeFrame: 6 Months
measure: Measure Biochemical Liver Function Via Lactate
timeFrame: Days 1-7
measure: Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies
timeFrame: 1 Day
measure: Number of Participants With Biliary Investigations and Biliary Interventions
timeFrame: 6 Months
measure: Number of Livers Randomized But Not Transplanted
timeFrame: 1 Day
measure: Number of Livers That Did Not Experience a Safety Event
timeFrame: 10 Days
measure: Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay
timeFrame: 6 Months
measure: Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire
timeFrame: 6 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic - Phoenix
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California (USC)
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles (UCLA)
state: California
city: San Francisco
country: United States
facility: University of California-San Francisco (UCSF)
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: Duke University
name: Stuart Knechtle, MD
role: PRINCIPAL_INVESTIGATOR
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.