WP01 - Normothermic Liver Preservation

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775162
• Other study ID #: WP01
• Status: Completed
• Phase: N/A
• Start date: October 9, 2016
• Est. completion date: February 19, 2021

Study information

• Verified date: July 2022
• Source: OrganOx Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: February 19, 2021
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Normothermic Machine Perfusion (NMP)

Other:
• Standard of Care (Ice)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Duke University	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	University of California - Los Angeles (UCLA)	Los Angeles	California
United States	University of Southern California (USC)	Los Angeles	California
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner	New Orleans	Louisiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic - Phoenix	Phoenix	Arizona
United States	Washington University	Saint Louis	Missouri
United States	University of California-San Francisco (UCSF)	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
OrganOx Ltd.	North American Science Associates (NAMSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Early Allograft Dysfunction (EAD)	EAD is a binary outcome defined by the presence of one of the following 3 outcomes: Serum bilirubin = 10 mg/dL at day 7 post-transplant; International normalized ratio (INR) = 1.6 at day 7 post-transplant; Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) > 2000 IU/L within the first 7 days post-transplant	7 Days
Secondary	Number of Participants With Primary Non-Function	Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation.	10 Days
Secondary	Number of Participants With Graft Survival		6 Months
Secondary	Number of Participants With Subject Survival		6 Months
Secondary	Number of Participants With Post-Reperfusion Syndrome	Post-Reperfusion Syndrome is defined in this study as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion.	1 Day
Secondary	Measure Biochemical Liver Function Via Bilirubin		6 Months
Secondary	Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)		6 Months
Secondary	Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)		6 Months
Secondary	Measure Biochemical Liver Function Via Aspartate Transaminase (AST)		6 Months
Secondary	Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)		6 Months
Secondary	Measure Biochemical Liver Function Via International Normalized Ratio (INR)	The international normalized ratio (INR) is a laboratory measurement of how long it takes blood to form a clot. It is calculated using the following formula: INR = (PT [test] / PT [control])^ISI; INR = international normalized ratio PT [test] = tested prothrombin time PT [control] = control prothrombin time ISI = international sensitivity index	6 Months
Secondary	Measure Biochemical Liver Function Via Lactate		Days 1-7
Secondary	Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies	Overall Degree of Ischemia Reperfusion Injury (IRI) was categorized as: None/Minimal: None or Polymorphonuclear Leukocytes (PMNs) in sinusoidal zone 3 with rare hepatocellular necrosis; Mild: Polymorphonuclear Leukocytes (PMNs) in sinusoidal zone 3 with = 1 cluster of necrotic hepatocytes; Moderate/Severe: Clusters of hepatocellular necrosis in > 50% of lobules or 60% of parenchyma or panlobular necrosis in > 1 lobule	1 Day
Secondary	Number of Participants With Biliary Investigations and Biliary Interventions		6 Months
Secondary	Number of Livers Randomized But Not Transplanted		1 Day
Secondary	Number of Livers That Did Not Experience a Safety Event	Number of livers that did not experience at least one of the following safety events: Early Allograft Dysfunction (EAD); Discard of a Retrieved Liver; Primary Non-Function (PNF)	10 Days
Secondary	Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay		6 Months
Secondary	Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire	The EQ-5D-5L Questionnaire is the standard layout for recording an adult person's current self-reported health state. It consists of a standard format for respondents to record their health state according to the EQ-5D-5L descriptive system and the EQ Visual Analog Scale (VAS). EQ-5D-5L index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. EQ-5D-5L is the name of the instrument and is not an acronym.	6 Months