18 and older, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Early Allograft Dysfunction (EAD)Primary· 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
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
20.6
14.5 – 28.5
Standard of Care (Ice)
23.7
17.1 – 31.9
Number of Participants With Primary Non-FunctionSecondary· 10 Days
Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation.
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
1
Standard of Care (Ice)
2
Number of Participants With Graft SurvivalSecondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
124
Standard of Care (Ice)
122
Number of Participants With Subject SurvivalSecondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
121
Standard of Care (Ice)
123
Number of Participants With Post-Reperfusion SyndromeSecondary· 1 Day
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.
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
8
Standard of Care (Ice)
19
Measure Biochemical Liver Function Via BilirubinSecondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
0.6
0.4 – 0.8
Standard of Care (Ice)
0.5
0.4 – 0.7
Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)Secondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
38.5
21.5 – 78.0
Standard of Care (Ice)
34.0
20.0 – 72.0
Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)Secondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
23.0
16.0 – 39.0
Standard of Care (Ice)
21.0
16.0 – 32.0
Measure Biochemical Liver Function Via Aspartate Transaminase (AST)Secondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
24.0
18.0 – 30.0
Standard of Care (Ice)
20.0
16.0 – 26.0
Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)Secondary· 6 Months
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
94.0
72.0 – 137.0
Standard of Care (Ice)
92.0
68.0 – 115.0
Measure Biochemical Liver Function Via International Normalized Ratio (INR)Secondary· 6 Months
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
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
1.0
1.0 – 1.1
Standard of Care (Ice)
1.0
1.0 – 1.1
Measure Biochemical Liver Function Via LactateSecondary· Days 1-7
Group
Value
95% CI
Normothermic Machine Perfusion (NMP)
1.4
1.0 – 2.1
Standard of Care (Ice)
1.5
1.0 – 1.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from the point of enrollment through study exit (12 months for subjects completing the study)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OrganOx Ltd.
Last refreshed: 29 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02775162.