Liver Transplantation After ex Vivo Liver Perfusion

Not Applicable

Not yet recruiting

• Conditions: Liver Transplant; Complications; Transplant; Failure, Liver; Liver Metastases; Transplant; Complication, Rejection; Liver Cancer; Transplant Dysfunction; Transplant
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT05951231
• Lead Sponsor: Oslo University Hospital

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.

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 Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-07-15
• Study First Posted: 2023-07-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Study Start: 2024-02
• Primary Completion: 2028-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liver transplanted patient	Liver transplantation	Patients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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.
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.
Postoperative complications	12 months	According to Clavien Dindo Classification
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.
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.
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.
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.
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.
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.
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 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.
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.
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 - 4 hours	4 hours	Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion 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.
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.
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.
Perfusate gas pH - during machine perfusion	24 hours	Perfusate gas pH during 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.
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 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.
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.
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.
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.
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.
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 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 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.
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 - 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 - 2.5 hours	2.5 hours	Microdialysis glucose 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 - 2.5 hours	2.5 hours	Glycerol levels from bile after normothermic machine perfusion - 2.5 hours 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 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 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 - 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 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 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.
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.
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 - 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 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.
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 - 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.
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 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.
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.
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.
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 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 bicarbonate (HCO3) - 4 hours after normothermic machine perfusion	4 hours	Bile gas HCO3 - 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 - 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
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 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 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.
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.
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.
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 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 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 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.
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 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.
Perfusate gas SO2 - during machine perfusion	24 hours	Perfusate gas SO2 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.
Machine flow during controlled oxygenated rewarming	1 hour	Machine flow (millilitre/hour)
Machine Resistance during controlled oxygenated rewarming	1 hour	Machine Resistance (millilitre/minute/millimetre Hg)
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 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 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.
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 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.
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 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 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.
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.
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 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 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.
Perfusate gas Ca - during machine perfusion	24 hours	Perfusate gas Ca 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.
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)
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 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 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 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.
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.
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 glucose - during machine perfusion	24 hours	Perfusate gas glucose during machine perfusion in extended criteria donors livers.
Length of stay	4 months	Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation.
Perfusate gas Na - during machine perfusion	24 hours	Perfusate gas Na during machine perfusion in extended criteria donors livers.
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 Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion	1 hour	Machine Resistance (millilitre/minute/millimetre Hg)
Machine Resistance during normothermic machine perfusion	2.5 hours	Machine Resistance (millilitre/minute/millimetre Hg)
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
Machine pressure during controlled oxygenated rewarming	1 hour	Machine pressure ((millimetre Hg))
Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion	1 hour	Machine fraction of oxygen (%)
Machine Fraction of oxygen during normothermic machine perfusion	2.5 hours	Machine fraction of oxygen (%)
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)
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
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	2.5 hours	Machine flow during normothermic machine perfusion (millilitre/hour)
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
Histopathology - liver tissue. Perfusion/reperfusion injury	During machine perfusion - 24 hours	Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury
Urea postoperative day 0	Postoperative day 0	Urea postoperative day 0 in the donated recipients (millimol/Litre)
Alkaline phosphatase postoperative day 1	Postoperative day 1	Alkaline phosphatase postoperative day 1 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)
Aspartate amino transferase postoperative day 4	Postoperative day 4	Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre)
Machine pressure during normothermic machine perfusion	2.5 hours	Machine pressure (millimetre Hg)
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)
Histopathology - bile duct. Cell death	During machine perfusion - 24 hours	Histological analysis of bile duct biopsies which are assessed for cell death
Histopathology - bile duct. Inflammation	During machine perfusion - 24 hours	Histological analysis of bile duct biopsies which are assessed for inflammation
Histopathology - liver tissue. Lipidomics	During machine perfusion - 24 hours	Histological analysis of parenchymal biopsies which are assessed for lipidomics
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 - 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 - liver tissue. Inflammation	During machine perfusion - 24 hours	Histological analysis of parenchymal biopsies which are assessed for inflammation
Histopathology - liver tissue. RNA sequencing	During machine perfusion - 24 hours	Histological analysis of parenchymal biopsies which are assessed for RNA sequencing
International normalized ratio on postoperative day 7	7 postoperative day	Blood sample from recipient: International normalized ratio on postoperative day 7
Aspartate amino transferase postoperative day 0	Postoperative day 0	Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre)
Bilirubin postoperative day 0	Postoperative day 0	Bilirubin postoperative day 0 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)
Urea postoperative day 6	Postoperative day 6	Urea postoperative day 6 in the donated recipients (millimol/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)
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 - bile duct. Lipidomics	During machine perfusion - 24 hours	Histological analysis of bile duct biopsies which are assessed for lipidomics
Alkaline phosphatase postoperative day 0	Postoperative day 0	Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre)
Bilirubin postoperative day 1	Postoperative day 1	Bilirubin postoperative day 1 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 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 2	Postoperative day 2	Urea postoperative day 2 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)
Gamma-glutamyl transferase postoperative day 3	Postoperative day 3	Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre)
Histopathology - bile duct. Endothelium properties	During machine perfusion - 24 hours	Histological analysis of bile duct biopsies which are assessed for endothelium properties
Urea postoperative day 1	Postoperative day 1	Urea postoperative day 1 in the donated recipients (millimol/Litre)
Urea postoperative day 7	Postoperative day 7	Urea postoperative day 7 in the donated recipients (millimol/Litre)
Alkaline phosphatase postoperative day 2	Postoperative day 2	Alkaline phosphatase 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)
Alanine amino transferase postoperative day 0	Postoperative day 0	Alanine amino transferase 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)
Bilirubin postoperative day 2	Postoperative day 2	Bilirubin postoperative day 2 in the donated recipients (micromol/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)
Gamma-glutamyl transferase postoperative day 2	Postoperative day 2	Gamma-glutamyl transferase postoperative day 2 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)
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)
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 7	Postoperative day 7	Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre)
Urea postoperative month 10	10 month after surgery	Urea postoperative month 10 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 day 4	Postoperative day 4	Alanine amino 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)
Alanine amino transferase postoperative month 2	2 month after surgery	Alanine amino transferase postoperative month 2 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)
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 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)
Bilirubin postoperative month 1	1 month after surgery	Bilirubin postoperative month 1 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)
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)
Alkaline phosphatase postoperative month 4	4 month after surgery	Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre)
Bilirubin postoperative month 4	4 month after surgery	Bilirubin postoperative month 4 in the donated recipients (micromol/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)
Aspartate amino transferase postoperative day 7	Postoperative day 7	Aspartate amino 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)
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 2	2 month after surgery	Urea postoperative month 2 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 11	11 month after surgery	Urea postoperative month 11 in the donated recipients (millimol/Litre)
Gamma-glutamyl transferase postoperative month 2	2 month after surgery	Gamma-glutamyl transferase postoperative month 2 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)
Aspartate amino transferase postoperative month 5	5 month after surgery	Aspartate amino transferase postoperative month 5 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)
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)
Gamma-glutamyl transferase postoperative day 7	Postoperative day 7	Gamma-glutamyl transferase postoperative day 7 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 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 5	5 month after surgery	Bilirubin postoperative month 5 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 3	3 month after surgery	Urea postoperative month 3 in the donated recipients (millimol/Litre)
Urea postoperative month 9	9 month after surgery	Urea postoperative month 9 in the donated recipients (millimol/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)
Alanine amino transferase postoperative month 4	4 month after surgery	Alanine amino transferase 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)
Aspartate amino transferase postoperative month 7	7 month after surgery	Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre)
The incidence of infections	Through study completion, an average of 12 months	The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment
Alkaline phosphatase postoperative month 8	8 month after surgery	Alkaline phosphatase postoperative month 8 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 3	3 month after surgery	Gamma-glutamyl transferase postoperative month 3 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)
Alkaline phosphatase postoperative month 5	5 month after surgery	Alkaline phosphatase postoperative month 5 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)
Alanine amino transferase postoperative month 8	8 month after surgery	Alanine amino transferase postoperative month 8 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)
Aspartate amino transferase postoperative month 10	10 month after surgery	Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre)
Postoperative microdialysis levels of glycerol	14 days	Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days
The incidence of symptomatic Non-anastomotic Biliary Strictures	12 months	The incidence of symptomatic non-anastomotic biliary strictures
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
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)
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)
Gamma-glutamyl transferase postoperative month 7	7 month after surgery	Gamma-glutamyl transferase postoperative month 7 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)
Alkaline phosphatase postoperative month 9	9 month after surgery	Alkaline phosphatase postoperative month 9 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)
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)
Postoperative microdialysis levels of lactate	14 days	Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days
Patient survival	Through study completion, an average of 12 months	Patient survival (days)
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 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)
Alkaline phosphatase postoperative month 7	7 month after surgery	Alkaline phosphatase postoperative month 7 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)
Alanine amino transferase postoperative month 9	9 month after surgery	Alanine amino 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)
Alanine amino transferase postoperative month 12	12 month after surgery	Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre)
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)
Vasopressor dosage	From 5 min before reperfusion, up to 20 minutes after reperfusion	Vasopressor dosage (microgram/kilogram/minutes)
Graft survival	Through study completion, an average of 12 months	Graft (censored and uncensored for patient death) survival (days)
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).
The incidence of asymptomatic Non-anastomotic Biliary Strictures	12 months	The incidence of asymptomatic non-anastomotic biliary strictures
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.
Aspartate amino transferase postoperative month 6	6 month after surgery	Aspartate amino transferase postoperative month 6 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)
Gamma-glutamyl transferase postoperative month 11	11 month after surgery	Gamma-glutamyl transferase postoperative month 11 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)
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
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.
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.
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 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)
Postoperative microdialysis levels of pyruvate	14 days	Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days
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)
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.
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.
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.
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.
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.
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.
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.