N/A
Completed N=267
WP01 - Normothermic Liver Preservation
Source: ClinicalTrials.gov NCT02775162 ↗Enrolled (actual)
267
Serious AEs
70.4%
Results posted
Jul 2022
Primary outcomePrimary: Percentage of Participants With Early Allograft Dysfunction (EAD) — 20.6; 23.7 percentage of participants
Summary
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Early Allograft Dysfunction (EAD) |
20.6; 23.7 | — |
| SECONDARY Number of Participants With Primary Non-Function |
1; 2 | — |
| SECONDARY Number of Participants With Graft Survival |
124; 122 | — |
| SECONDARY Number of Participants With Subject Survival |
121; 123 | — |
| SECONDARY Number of Participants With Post-Reperfusion Syndrome |
8; 19 | — |
| SECONDARY Measure Biochemical Liver Function Via Bilirubin |
0.6; 0.5 | — |
| SECONDARY Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT) |
38.5; 34.0 | — |
| SECONDARY Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT) |
23.0; 21.0 | — |
| SECONDARY Measure Biochemical Liver Function Via Aspartate Transaminase (AST) |
24.0; 20.0 | — |
| SECONDARY Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP) |
94.0; 92.0 | — |
| SECONDARY Measure Biochemical Liver Function Via International Normalized Ratio (INR) |
1.0; 1.0 | — |
| SECONDARY Measure Biochemical Liver Function Via Lactate |
1.4; 1.5 | — |
| SECONDARY Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies |
123; 117; 10; 5; 0; 0 | — |
| SECONDARY Number of Participants With Biliary Investigations and Biliary Interventions |
14; 16; 12; 11 | — |
| SECONDARY Number of Livers Randomized But Not Transplanted |
56; 61 | — |
| SECONDARY Number of Livers That Did Not Experience a Safety Event |
147; 137 | — |
| SECONDARY Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay |
4.6; 4.2; 14.3; 13.3 | — |
| SECONDARY Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire |
0.9; 0.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02775162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.