NCT02775162CompletedNot Applicable
A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
OrganOx Ltd.30 sites in 1 country267 target enrollmentStarted: October 9, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 267
- Locations
- 30
- Primary Endpoint
- Percentage of Participants With Early Allograft Dysfunction (EAD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percentage of Participants With Early Allograft Dysfunction (EAD)
Time Frame: 7 Days
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
Secondary Outcomes
- Number of Participants With Primary Non-Function(10 Days)
- Number of Participants With Graft Survival(6 Months)
- Number of Participants With Subject Survival(6 Months)
- Number of Participants With Post-Reperfusion Syndrome(1 Day)
- Measure Biochemical Liver Function Via Bilirubin(6 Months)
- Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)(6 Months)
- Measure Biochemical Liver Function Via Aspartate Transaminase (AST)(6 Months)
- Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)(6 Months)
- Measure Biochemical Liver Function Via International Normalized Ratio (INR)(6 Months)
- Measure Biochemical Liver Function Via Lactate(Days 1-7)
- Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies(1 Day)
- Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)(6 Months)
- Number of Participants With Biliary Investigations and Biliary Interventions(6 Months)
- Number of Livers Randomized But Not Transplanted(1 Day)
- Number of Livers That Did Not Experience a Safety Event(10 Days)
- Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay(6 Months)
- Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire(6 Months)
Investigators
Study Sites (30)
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