EVOLVE: Liver Transplantation After ex Vivo Liver Perfusion

Sponsor

Oslo University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05951231

Collaborator

South-Eastern Norway Regional Health Authority (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended criteria donor (ECD) livers) liver on a liver perfusion machine. A liver perfusion machine can simulate liver transplantation and enables functional/quality testing before transplantation. The machine will hopefully also make marginal livers more functional by reducing ischemia- & reperfusion injury. A marginal donor liver is perfused ex situ with oxygenated blood from a blood donor on a machine. The liver can be tested here for function using internationally recognized criteria. At the same time, the investigators will carry out analyzes with microdialysis which can give a better picture of organ function and damage. Additionally, various samples of the liver and perfusate will be collected. Liver that achieves criteria for transplantation will be offered to the recipient.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications Transplant; Failure, Liver Transplant Dysfunction Transplant; Complication, Rejection Transplant Liver Metastases Liver Cancer	Procedure: Liver transplantation	N/A

Detailed Description

The study is a single-center, prospective, open-label cohort study designed to determine the efficacy of liver perfusion of marginal ECD livers on a perfusion machine before liver transplantation. Donor livers will be preserved with standard cooling followed by three perfusion modes (Dual hypothermic oxygenated machine perfusion (DHOPE) / Controlled oxygenated rewarming (COR) / Normothermic machine perfusion (NMP)), a method used internationally to pre-treating marginal livers before liver transplantation and which able testing of function and quality before a transplantation is performed. Only livers that fulfill international criteria (Groningen criteria) will be approved for Ltx. In this study microdialysis will be used to monitoring the liver during machine perfusion and up to 14 days in the postoperative course to monitor the function of the liver. The hypothesis is that microdialysis will provide a better prediction of liver function than the existing Groeningen criteria. The investigators expect that most included patients, who receive ECD livers perfused on a machine, will receive a postoperative well-functioning liver graft which entails a significant survival benefit. The study is designed as a cohort study because included patients have a very poor prognosis (median overall survival of approx. 6 months) and others treatment options are lacking. The primary objective is to establish definitive, objective criteria for pre-transplant liver function by defining a threshold value for microdialysis parameters (especially lactate) between donor livers that will restore function and those that will not during ex vivo machine perfusion in ECD livers, which are superior to established criteria (Groeningen and Viability testing and transplantation of marginal livers (VITTAL) criteria)). The primary endpoint is microdialysis lactate level between donor livers after 4 hours of normothermic machine perfusion in ECD livers.

The follow-up period is 12 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single center, prospective, open, observational studySingle center, prospective, open, observational study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Sep 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liver transplanted patient Patients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine	Procedure: Liver transplantation Patients who receive an ECD liver after an ex-vivo liver perfusion where the liver has been tested for function and approved according to international functional criteria (Groeningen criteria)
No Intervention: Non-liver transplanted patient Patients who are not offered a liver transplantation during the inclusion period

Arm

Intervention/Treatment

Active Comparator: Liver transplanted patient

Patients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine

Procedure: Liver transplantation

Patients who receive an ECD liver after an ex-vivo liver perfusion where the liver has been tested for function and approved according to international functional criteria (Groeningen criteria)

No Intervention: Non-liver transplanted patient

Patients who are not offered a liver transplantation during the inclusion period

Outcome Measures

Primary Outcome Measures

Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours [4 hours]
Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.

Secondary Outcome Measures

Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis lactate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Microdialysis lactate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Microdialysis pyruvate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Microdialysis glycerol level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Microdialysis glucose level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Microdialysis lactate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Microdialysis glycerol level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Microdialysis glucose level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Microdialysis pyruvate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis glucose level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours [4 hours]
Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis pyruvate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours [4 hours]
Microdialysis pyruvate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis glycerol level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours [4 hours]
Microdialysis glycerol level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours [4 hours]
Microdialysis lactate level from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis lactate level from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours [4 hours]
Microdialysis glucose levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis glucose levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours [4 hours]
Microdialysis pyruvate levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours [2.5 hours]
Microdialysis pyruvate levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours [4 hours]
Glycerol levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours [2.5 hours]
Glycerol levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Glycerol levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Glucose levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Lactate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Pyruvate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Pyruvate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Glycerol levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Lactate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Glucose levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Bile gases pH - 4 hours after normothermic machine perfusion [4 hours]
Bile gas pH - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases pH - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas pH - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Lactate - 4 hours after normothermic machine perfusion [4 hours]
Bile gas Lactate - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Lactate - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas Lactate - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Glucose - 4 hours after normothermic machine perfusion [4 hours]
Bile gas Glucose - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Glucose - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas Glucose - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas O2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases O2 - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas O2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas CO2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases CO2 - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas CO2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas HCO3 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases HCO3 - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas HCO3 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases base excess (BE) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas BE - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion [4 hours]
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion [4 hours]
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [4 hours]
Ischemia/reperfusion injury in liver biopsies, graded according to Tian Y et al et al, Liver transplant 2015; nil, mild, moderate, and severe. - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [4 hours]
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Ischemia/reperfusion injury - before machine perfusion [1 minute]
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - before machine perfusion in extended criteria donors livers
Ischemia/reperfusion damage - before machine perfusion [1 minute]
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - before machine perfusion in extended criteria donors livers
Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion [2.5 hours]
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion [2.5 hours]
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases BE - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas BE - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas SO2- 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases SO2 - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas SO2- 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion [4 hours]
Bile gas Hb - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Hb - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas Hb - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases sodium (Na) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas Na - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Na - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas Na - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases potassium (K) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas K - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases K - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas K - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion [4 hours]
Bile gas Ca - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gases Ca - 2.5 hours after normothermic machine perfusion [2.5 hours]
Bile gas Ca - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion [2.5 hours]
Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion [2 hours]
Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion [1 hour]
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion [1 hours]
Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Perfusate gas Ca - during machine perfusion [24 hours]
Perfusate gas Ca during machine perfusion in extended criteria donors livers.
Perfusate gas pH - during machine perfusion [24 hours]
Perfusate gas pH during machine perfusion in extended criteria donors livers.
Perfusate gas SO2 - during machine perfusion [24 hours]
Perfusate gas SO2 during machine perfusion in extended criteria donors livers.
Perfusate gas O2 - during machine perfusion [24 hours]
Perfusate gas O2 during machine perfusion in extended criteria donors livers.
Perfusate gas CO2 - during machine perfusion [24 hours]
Perfusate gas CO2 during machine perfusion in extended criteria donors livers.
Perfusate gas K - during machine perfusion [24 hours]
Perfusate gas K during machine perfusion in extended criteria donors livers.
Perfusate gas Na - during machine perfusion [24 hours]
Perfusate gas Na during machine perfusion in extended criteria donors livers.
Perfusate gas BE - during machine perfusion [24 hours]
Perfusate gas BE during machine perfusion in extended criteria donors livers.
Perfusate gas HCO3 - during machine perfusion [24 hours]
Perfusate gas HCO3 during machine perfusion in extended criteria donors livers.
Perfusate gas hemoglobin - during machine perfusion [24 hours]
Perfusate gas hemoglobin during machine perfusion in extended criteria donors livers.
Perfusate gas lactate - during machine perfusion [24 hours]
Perfusate gas lactate during machine perfusion in extended criteria donors livers.
Perfusate gas glucose - during machine perfusion [24 hours]
Perfusate gas glucose during machine perfusion in extended criteria donors livers.
Postoperative complications [12 months]
According to Clavien Dindo Classification
Length of stay [4 months]
Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation.
Machine flow during controlled oxygenated rewarming [1 hour]
Machine flow (millilitre/hour)
Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion [1 hour]
Machine flow (millilitre/hour)
Machine pressure during controlled oxygenated rewarming [1 hour]
Machine pressure ((millimetre Hg))
Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion [1 hour]
Machine pressure ((millimetre Hg))
Machine Fraction of oxygen during controlled oxygenated rewarming [1 hour]
Machine fraction of oxygen (%)
Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion [1 hour]
Machine fraction of oxygen (%)
Machine Resistance during controlled oxygenated rewarming [1 hour]
Machine Resistance (millilitre/minute/millimetre Hg)
Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion [1 hour]
Machine Resistance (millilitre/minute/millimetre Hg)
Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion [2 hours]
Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion flow (millilitre/hour)
Machine flow during normothermic machine perfusion [4 hours]
Machine flow during normothermic machine perfusion (millilitre/hour)
Machine flow during normothermic machine perfusion [2.5 hours]
Machine flow during normothermic machine perfusion (millilitre/hour)
Machine pressure during normothermic machine perfusion [4 hours]
Machine pressure (millimetre Hg)
Machine pressure during normothermic machine perfusion [2.5 hours]
Machine pressure (millimetre Hg)
Machine Fraction of oxygen during normothermic machine perfusion [4 hours]
Machine fraction of oxygen (%)
Machine Fraction of oxygen during normothermic machine perfusion [2.5 hours]
Machine fraction of oxygen (%)
Machine Resistance during normothermic machine perfusion [4 hours]
Machine Resistance (millilitre/minute/millimetre Hg)
Machine Resistance during normothermic machine perfusion [2.5 hours]
Machine Resistance (millilitre/minute/millimetre Hg)
Total preservation time [48 hours]
Total preservation time (machine perfusion time)
Alanine amino transferase in perfusate during machine perfusion [24 hours]
Alanine amino transferase in perfusate during machine perfusion (U/Litre)
Aspartate amino transferase in perfusate during machine perfusion [24 hours]
Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
Alkaline phosphatase in perfusate during machine perfusion [24 hours]
Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
Gamma-glutamyl transferase in perfusate during machine perfusion [24 hours]
Gamma-glutamyl transferase in perfusate during machine perfusion (U/Litre)
Urea in perfusate during machine perfusion [24 hours]
Urea in perfusate during machine perfusion (millimol/Litre)
Bilirubin in perfusate during machine perfusion [24 hours]
Bilirubin in perfusate during machine perfusion (micromol/Litre)
Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion [24 hours]
Different cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion [24 hours]
Different cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion [24 hours]
Different cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
Histopathology - liver tissue. Mitochondrial function [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for mitochondrial function.
Histopathology - bile duct. Mitochondrial function [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for mitochondrial function.
Histopathology - liver tissue. Perfusion/reperfusion injury [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury
Histopathology - bile duct. Perfusion/reperfusion injury [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for perfusion/reperfusion injury
Histopathology - liver tissue. Cell death [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for cell death
Histopathology - bile duct. Cell death [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for cell death
Histopathology - liver tissue. Inflammation [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for inflammation
Histopathology - bile duct. Inflammation [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for inflammation
Histopathology - liver tissue. Metabolomics [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for metabolomics
Histopathology - bileduct. Metabolomics [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for metabolomics
Histopathology - liver tissue. Lipidomics [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for lipidomics
Histopathology - bile duct. Lipidomics [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for lipidomics
Histopathology - liver tissue. RNA sequencing [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for RNA sequencing
Histopathology - bile duct. RNA sequencing [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for RNA sequencing
Histopathology - liver tissue. Endothelium properties [During machine perfusion - 24 hours]
Histological analysis of parenchymal biopsies which are assessed for endothelium properties
Histopathology - bile duct. Endothelium properties [During machine perfusion - 24 hours]
Histological analysis of bile duct biopsies which are assessed for endothelium properties
International normalized ratio on postoperative day 7 [7 postoperative day]
Blood sample from recipient: International normalized ratio on postoperative day 7
Alanine amino transferase postoperative day 0 [Postoperative day 0]
Alanine amino transferase postoperative day 0 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 0 [Postoperative day 0]
Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 0 [Postoperative day 0]
Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 0 [Postoperative day 0]
Gamma-glutamyl transferase postoperative day 0 in the donated recipients (U/Litre)
Urea postoperative day 0 [Postoperative day 0]
Urea postoperative day 0 in the donated recipients (millimol/Litre)
Bilirubin postoperative day 0 [Postoperative day 0]
Bilirubin postoperative day 0 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 1 [Postoperative day 1]
Bilirubin postoperative day 1 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 2 [Postoperative day 2]
Bilirubin postoperative day 2 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 3 [Postoperative day 3]
Bilirubin postoperative day 3 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 4 [Postoperative day 4]
Bilirubin postoperative day 4 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 5 [Postoperative day 5]
Bilirubin postoperative day 5 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 6 [Postoperative day 6]
Bilirubin postoperative day 6 in the donated recipients (micromol/Litre)
Bilirubin postoperative day 7 [Postoperative day 7]
Bilirubin postoperative day 7 in the donated recipients (micromol/Litre)
Urea postoperative day 1 [Postoperative day 1]
Urea postoperative day 1 in the donated recipients (millimol/Litre)
Urea postoperative day 2 [Postoperative day 2]
Urea postoperative day 2 in the donated recipients (millimol/Litre)
Urea postoperative day 3 [Postoperative day 3]
Urea postoperative day 3 in the donated recipients (millimol/Litre)
Urea postoperative day 4 [Postoperative day 4]
Urea postoperative day 4 in the donated recipients (millimol/Litre)
Urea postoperative day 5 [Postoperative day 5]
Urea postoperative day 5 in the donated recipients (millimol/Litre)
Urea postoperative day 6 [Postoperative day 6]
Urea postoperative day 6 in the donated recipients (millimol/Litre)
Urea postoperative day 7 [Postoperative day 7]
Urea postoperative day 7 in the donated recipients (millimol/Litre)
Aspartate amino transferase postoperative day 1 [Postoperative day 1]
Aspartate amino transferase postoperative day 1 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 1 [Postoperative day 1]
Alkaline phosphatase postoperative day 1 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 1 [Postoperative day 1]
Gamma-glutamyl transferase postoperative day 1 in the donated recipients (U/Litre)
Alanine amino transferase postoperative day 2 [Postoperative day 2]
Alanine amino transferase postoperative day 2 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 2 [Postoperative day 2]
Aspartate amino transferase postoperative day 2 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 2 [Postoperative day 2]
Alkaline phosphatase postoperative day 2 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 2 [Postoperative day 2]
Gamma-glutamyl transferase postoperative day 2 in the donated recipients (U/Litre)
Alanine amino transferase postoperative day 3 [Postoperative day 3]
Alanine amino transferase postoperative day 3 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 3 [Postoperative day 3]
Aspartate amino transferase postoperative day 3 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 3 [Postoperative day 3]
Alkaline phosphatase postoperative day 3 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 3 [Postoperative day 3]
Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre)
Alanine amino transferase postoperative day 4 [Postoperative day 4]
Alanine amino transferase postoperative day 4 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 4 [Postoperative day 4]
Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 4 [Postoperative day 4]
Alkaline phosphatase postoperative day 4 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 4 [Postoperative day 4]
Gamma-glutamyl transferase postoperative day 4 in the donated recipients (U/Litre)
Alanine amino transferase postoperative day 5 [Postoperative day 5]
Alanine amino transferase postoperative day 5 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 5 [Postoperative day 5]
Aspartate amino transferase postoperative day 5 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 5 [Postoperative day 5]
Alkaline phosphatase postoperative day 5 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 5 [Postoperative day 5]
Gamma-glutamyl transferase postoperative day 5 in the donated recipients (U/Litre)
Alanine amino transferase postoperative day 6 [Postoperative day 6]
Alanine amino transferase postoperative day 6 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 6 [Postoperative day 6]
Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 6 [Postoperative day 6]
Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 6 [Postoperative day 6]
Gamma-glutamyl transferase postoperative day 6 in the donated recipients (U/Litre)
Alanine amino transferase postoperative day 7 [Postoperative day 7]
Alanine amino transferase postoperative day 7 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative day 7 [Postoperative day 7]
Aspartate amino transferase postoperative day 7 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative day 7 [Postoperative day 7]
Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative day 7 [Postoperative day 7]
Gamma-glutamyl transferase postoperative day 7 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 1 [1 month after surgery]
Alanine amino transferase postoperative month 1 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 1 [1 month after surgery]
Aspartate amino transferase postoperative month 1 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 1 [1 month after surgery]
Alkaline phosphatase postoperative month 1 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 1 [1 month after surgery]
Gamma-glutamyl transferase postoperative month 1 in the donated recipients (U/Litre)
Urea postoperative month 1 [1 month after surgery]
Urea postoperative month 1 in the donated recipients (millimol/Litre)
Bilirubin postoperative month 1 [1 month after surgery]
Bilirubin postoperative month 1 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 2 [2 month after surgery]
Bilirubin postoperative month 2 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 3 [3 month after surgery]
Bilirubin postoperative month 3 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 4 [4 month after surgery]
Bilirubin postoperative month 4 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 5 [5 month after surgery]
Bilirubin postoperative month 5 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 6 [6 month after surgery]
Bilirubin postoperative month 6 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 7 [7 month after surgery]
Bilirubin postoperative month 7 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 8 [8 month after surgery]
Bilirubin postoperative month 8 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 9 [9 month after surgery]
Bilirubin postoperative month 9 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 10 [10 month after surgery]
Bilirubin postoperative month 10 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 11 [11 month after surgery]
Bilirubin postoperative month 11 in the donated recipients (micromol/Litre)
Bilirubin postoperative month 12 [12 month after surgery]
Bilirubin postoperative month 12 in the donated recipients (micromol/Litre)
Urea postoperative month 2 [2 month after surgery]
Urea postoperative month 2 in the donated recipients (millimol/Litre)
Urea postoperative month 3 [3 month after surgery]
Urea postoperative month 3 in the donated recipients (millimol/Litre)
Urea postoperative month 4 [4 month after surgery]
Urea postoperative month 4 in the donated recipients (millimol/Litre)
Urea postoperative month 5 [5 month after surgery]
Urea postoperative month 5 in the donated recipients (millimol/Litre)
Urea postoperative month 6 [6 month after surgery]
Urea postoperative month 6 in the donated recipients (millimol/Litre)
Urea postoperative month 7 [7 month after surgery]
Urea postoperative month 7 in the donated recipients (millimol/Litre)
Urea postoperative month 8 [8 month after surgery]
Urea postoperative month 8 in the donated recipients (millimol/Litre)
Urea postoperative month 9 [9 month after surgery]
Urea postoperative month 9 in the donated recipients (millimol/Litre)
Urea postoperative month 10 [10 month after surgery]
Urea postoperative month 10 in the donated recipients (millimol/Litre)
Urea postoperative month 11 [11 month after surgery]
Urea postoperative month 11 in the donated recipients (millimol/Litre)
Urea postoperative month 12 [12 month after surgery]
Urea postoperative month 12 in the donated recipients (millimol/Litre)
Alanine amino transferase postoperative month 2 [2 month after surgery]
Alanine amino transferase postoperative month 2 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 2 [2 month after surgery]
Aspartate amino transferase postoperative month 2 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 2 [2 month after surgery]
Alkaline phosphatase postoperative month 2 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 2 [2 month after surgery]
Gamma-glutamyl transferase postoperative month 2 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 3 [3 month after surgery]
Alanine amino transferase postoperative month 3 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 3 [3 month after surgery]
Aspartate amino transferase postoperative month 3 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 3 [3 month after surgery]
Alkaline phosphatase postoperative month 3 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 3 [3 month after surgery]
Gamma-glutamyl transferase postoperative month 3 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 4 [4 month after surgery]
Alanine amino transferase postoperative month 4 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 4 [4 month after surgery]
Aspartate amino transferase postoperative month 4 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 4 [4 month after surgery]
Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 4 [4 month after surgery]
Gamma-glutamyl transferase postoperative month 4 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 5 [5 month after surgery]
Alanine amino transferase postoperative month 5 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 5 [5 month after surgery]
Aspartate amino transferase postoperative month 5 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 5 [5 month after surgery]
Alkaline phosphatase postoperative month 5 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 5 [5 month after surgery]
Gamma-glutamyl transferase postoperative month 5 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 6 [6 month after surgery]
Alanine amino transferase postoperative month 6 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 6 [6 month after surgery]
Aspartate amino transferase postoperative month 6 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 6 [6 month after surgery]
Alkaline phosphatase postoperative month 6 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 6 [6 month after surgery]
Gamma-glutamyl transferase postoperative month 6 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 7 [7 month after surgery]
Alanine amino transferase postoperative month 7 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 7 [7 month after surgery]
Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 7 [7 month after surgery]
Alkaline phosphatase postoperative month 7 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 7 [7 month after surgery]
Gamma-glutamyl transferase postoperative month 7 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 8 [8 month after surgery]
Alanine amino transferase postoperative month 8 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 8 [8 month after surgery]
Aspartate amino transferase postoperative month 8 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 8 [8 month after surgery]
Alkaline phosphatase postoperative month 8 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 8 [8 month after surgery]
Gamma-glutamyl transferase postoperative month 8 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 9 [9 month after surgery]
Alanine amino transferase postoperative month 9 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 9 [9 month after surgery]
Aspartate amino transferase postoperative month 9 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 9 [9 month after surgery]
Alkaline phosphatase postoperative month 9 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 9 [9 month after surgery]
Gamma-glutamyl transferase postoperative month 9 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 10 [10 month after surgery]
Alanine amino transferase postoperative month 10 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 10 [10 month after surgery]
Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 10 [10 month after surgery]
Alkaline phosphatase postoperative month 10 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 10 [10 month after surgery]
Gamma-glutamyl transferase postoperative month 10 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 11 [11 month after surgery]
Alanine amino transferase postoperative month 11 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 11 [11 month after surgery]
Aspartate amino transferase postoperative month 11 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 11 [11 month after surgery]
Alkaline phosphatase postoperative month 11 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 11 [11 month after surgery]
Gamma-glutamyl transferase postoperative month 11 in the donated recipients (U/Litre)
Alanine amino transferase postoperative month 12 [12 month after surgery]
Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre)
Aspartate amino transferase postoperative month 12 [12 month after surgery]
Aspartate amino transferase postoperative month 12 in the donated recipients (U/Litre)
Alkaline phosphatase postoperative month 12 [12 month after surgery]
Alkaline phosphatase postoperative month 12 in the donated recipients (U/Litre)
Gamma-glutamyl transferase postoperative month 12 [12 month after surgery]
Gamma-glutamyl transferase postoperative month 12 in the donated recipients (U/Litre)
Postoperative microdialysis levels of lactate [14 days]
Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days
Postoperative microdialysis levels of pyruvate [14 days]
Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days
Postoperative microdialysis levels of glycerol [14 days]
Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days
Postoperative microdialysis levels of glucose [14 days]
Postoperative microdialysis levels of glucose in transplanted livers the first 14 postoperative days
Systolic blood pressure [From 5 min before reperfusion, up to 20 minutes after reperfusion]
Systolic blood pressure (millimeter Hg)
Diastolic blood pressure [From 5 min before reperfusion, up to 20 minutes after reperfusion]
Diastolic blood pressure (millimeter Hg)
Heart rate [From 5 min before reperfusion, up to 20 minutes after reperfusion]
Heart rate (Beats/minute)
Vasopressor dosage [From 5 min before reperfusion, up to 20 minutes after reperfusion]
Vasopressor dosage (microgram/kilogram/minutes)
Patient survival [Through study completion, an average of 12 months]
Patient survival (days)
Graft survival [Through study completion, an average of 12 months]
Graft (censored and uncensored for patient death) survival (days)
Number of deaths [7 days after transplantation]
Number of deaths first 7 days after transplantation
Number of retransplantation [7 days after transplantation]
Number of retransplantation first 7 days after transplantation
Incidens of new onset diabetes after transplantation [Through study completion, an average of 12 months]
New onset diabetes after transplantation after transplantation. New onset diabetes after transplantation is defined according to the World Health Organization criteria (Report 2003 S5-20).
Estimated glomerular filtration rate - Renal function [Through study completion, an average of 12 months]
Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease equation.
The incidence of symptomatic Non-anastomotic Biliary Strictures [6 months]
The incidence of symptomatic non-anastomotic biliary strictures
The incidence of asymptomatic Non-anastomotic Biliary Strictures [6 months]
The incidence of asymptomatic non-anastomotic biliary strictures
The incidence of asymptomatic Non-anastomotic Biliary Strictures [12 months]
The incidence of asymptomatic non-anastomotic biliary strictures
The incidence of symptomatic Non-anastomotic Biliary Strictures [12 months]
The incidence of symptomatic non-anastomotic biliary strictures
The severity of Non-anastomotic Biliary Strictures [Through study completion, an average of 12 months]
The severity of Non-anastomotic Biliary Strictures based on a scoring system described by Buis et. al (mild, moderate, or severe)
The location of Non-anastomotic Biliary Strictures [Through study completion, an average of 12 months]
The location of Non-anastomotic Biliary Strictures is assessed by images of the magnetic resonance cholangiopancreatography
The incidence of infections [Through study completion, an average of 12 months]
The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment
Lactate level in microdialysate from liver tissue - 4 hours [4 hours]
Microdialysis lactate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours [4 hours]
Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours [4 hours]
Glycerol level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours [4 hours]
Glucose level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours [2 hours]
Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour [1 hour]
Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours [2 hour]
Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours [2 hour]
Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

Other Outcome Measures

Donor associated variables - age [1 hour]
Age of the donor (years)
Donor associated variables - liver steatosis [1 hour]
Assessment of liver steatosis (%)
Donor associated variables - gender [1 hour]
Gender of donor
Donor associated variables - Body mass index [1 hour]
Body mass index of donor (kilogram/meter2)
Donor associated variables - weight of the liver [1 hour]
Weight of the liver (gram)
Ischemia time - warm [12 hour]
Estimation of warm ischemia time (minutes)
Ischemia time - cold [12 hour]
Estimation of cold ischemia time (minutes)
Donor associated variables - Donor risk index [1 hour]
Donor risk index score - Increasing donor risk index is associated with higher discard rates among deceased donor livers procured for transplant. Low value of 1= best prognosis. High value of 40 = worst prognosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent
≥ 18 years
Indication for liver transplantation (one criteria must be met):
Colorectal cancer patients who have received 1st and 2nd line chemotherapy where the treatment has been stopped due to progression or toxicity and the patient is not eligible for SECA-2 (Survival Following Liver Transplantation for Patients With Nonresectable Liver-only Colorectal Metastases) study.
Hepatocellular carcinoma patients who are not suitable for standard liver transplantation, liver resection or local treatment (Transarterial Chemoembolisation or Selective internal radiotherapy). The patients must have progression or intolerance (toxicity) for immune checkpoint inhibitors or 1st line treatment.
Cholangiocarcinoma patients who have progression or intolerance to first-line chemotherapy.
Benign liver disease with urgent need for transplantation within months, but no regular graft is available.
Life expectancy ≤ 6 months
Willing, able and expected cooperation to attend follow-up examinations
Patients who have a need for liver transplantation but cannot participate in other transplant studies or participation in another clinical trial with randomization to liver transplantation.

For malignant disease the following criteria must be met:

Good performance status assessed at the discretion of the treating physician.
ECOG (Eastern Cooperative Oncology Group) 0 or 1
Satisfactory blood tests
Hemoglobin >8 g/dl
Neutrophiles >1.0 (after any Granulocyte colony-stimulating factor)
Platelets >75
Bilirubin <1.5 x upper normal level
ASAT (Aspartate aminotransferase), ALAT (alanine aminotransferase) <5 x upper normal level
Albumin above lower normal level.

Exclusion Criteria:

Already listed for ordinary Ltx with expectance of getting offered a regular liver graft within a reasonable time-frame.
Patients included in the control arm of the SECA-3 study or the Excalibur studies except for the Ltx arm of the Excalibur I study.
Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial.
Any reason why, in the opinion of the investigator, the patient should not participate.