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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05951231
Other study ID # 598448
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date February 2029

Study information

Verified date October 2023
Source Oslo University Hospital
Contact Søren E Pischke, MD, PhD
Phone 45486579
Email s.e.pischke@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date February 2029
Est. primary completion date February 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Intervention

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)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital South-Eastern Norway Regional Health Authority

Outcome

Type Measure Description Time frame Safety issue
Other Donor associated variables - age Age of the donor (years) 1 hour
Other Donor associated variables - liver steatosis Assessment of liver steatosis (%) 1 hour
Other Donor associated variables - gender Gender of donor 1 hour
Other Donor associated variables - Body mass index Body mass index of donor (kilogram/meter2) 1 hour
Other Donor associated variables - weight of the liver Weight of the liver (gram) 1 hour
Other Ischemia time - warm Estimation of warm ischemia time (minutes) 12 hour
Other Ischemia time - cold Estimation of cold ischemia time (minutes) 12 hour
Other Donor associated variables - Donor risk index 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 1 hour
Primary Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours Microdialysis lactate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 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. 2 hours
Secondary Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 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. 2 hours
Secondary Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 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. 2 hours
Secondary Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 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. 2 hours
Secondary Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour Microdialysis lactate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour Microdialysis glycerol level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour Microdialysis glucose level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour Microdialysis pyruvate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours Microdialysis glucose level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours Microdialysis pyruvate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours Microdialysis pyruvate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours Microdialysis glycerol level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours Microdialysis glycerol level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours Microdialysis lactate level from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers. 4 hours
Secondary Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours Microdialysis lactate level from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers. 2.5 hours
Secondary Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours Microdialysis glucose levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers. 4 hours
Secondary Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours Microdialysis glucose levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers. 2.5 hours
Secondary Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours Microdialysis pyruvate levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers. 4 hours
Secondary Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours Microdialysis pyruvate levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers. 2.5 hours
Secondary Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours Glycerol levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers. 4 hours
Secondary Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours Glycerol levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers. 2.5 hours
Secondary Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour Glycerol levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers. 1 hour
Secondary Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour Glucose levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers. 1 hour
Secondary Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour Lactate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers. 1 hour
Secondary Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour Pyruvate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers. 1 hour
Secondary Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours Pyruvate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers. 2 hours
Secondary Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours Glycerol levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers. 2 hours
Secondary Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours Lactate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers. 2 hours
Secondary Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours Glucose levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers. 2 hours
Secondary Bile gases pH - 4 hours after normothermic machine perfusion Bile gas pH - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases pH - 2.5 hours after normothermic machine perfusion Bile gas pH - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases Lactate - 4 hours after normothermic machine perfusion Bile gas Lactate - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases Lactate - 2.5 hours after normothermic machine perfusion Bile gas Lactate - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases Glucose - 4 hours after normothermic machine perfusion Bile gas Glucose - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases Glucose - 2.5 hours after normothermic machine perfusion Bile gas Glucose - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion Bile gas O2 - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases O2 - 2.5 hours after normothermic machine perfusion Bile gas O2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion Bile gas CO2 - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases CO2 - 2.5 hours after normothermic machine perfusion Bile gas CO2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion Bile gas HCO3 - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases HCO3 - 2.5 hours after normothermic machine perfusion Bile gas HCO3 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases base excess (BE) - 4 hours after normothermic machine perfusion Bile gas BE - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion 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. 4 hours
Secondary Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion 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. 4 hours
Secondary Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion 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. 4 hours
Secondary Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion 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. 4 hours
Secondary Ischemia/reperfusion injury - before machine perfusion 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 1 minute
Secondary Ischemia/reperfusion damage - before machine perfusion 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 1 minute
Secondary Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 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 1 hour
Secondary Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 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 1 hour
Secondary Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion 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. 2.5 hours
Secondary Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion 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. 2.5 hours
Secondary Bile gases BE - 2.5 hours after normothermic machine perfusion Bile gas BE - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion Bile gas SO2- 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases SO2 - 2.5 hours after normothermic machine perfusion Bile gas SO2- 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion Bile gas Hb - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases Hb - 2.5 hours after normothermic machine perfusion Bile gas Hb - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases sodium (Na) - 4 hours after normothermic machine perfusion Bile gas Na - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases Na - 2.5 hours after normothermic machine perfusion Bile gas Na - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases potassium (K) - 4 hours after normothermic machine perfusion Bile gas K - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases K - 2.5 hours after normothermic machine perfusion Bile gas K - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion Bile gas Ca - 4 hours after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Bile gases Ca - 2.5 hours after normothermic machine perfusion Bile gas Ca - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion in extended criteria donors livers. 2.5 hours
Secondary Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hours
Secondary Perfusate gas Ca - during machine perfusion Perfusate gas Ca during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas pH - during machine perfusion Perfusate gas pH during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas SO2 - during machine perfusion Perfusate gas SO2 during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas O2 - during machine perfusion Perfusate gas O2 during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas CO2 - during machine perfusion Perfusate gas CO2 during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas K - during machine perfusion Perfusate gas K during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas Na - during machine perfusion Perfusate gas Na during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas BE - during machine perfusion Perfusate gas BE during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas HCO3 - during machine perfusion Perfusate gas HCO3 during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas hemoglobin - during machine perfusion Perfusate gas hemoglobin during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas lactate - during machine perfusion Perfusate gas lactate during machine perfusion in extended criteria donors livers. 24 hours
Secondary Perfusate gas glucose - during machine perfusion Perfusate gas glucose during machine perfusion in extended criteria donors livers. 24 hours
Secondary Postoperative complications According to Clavien Dindo Classification 12 months
Secondary Length of stay Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation. 4 months
Secondary Machine flow during controlled oxygenated rewarming Machine flow (millilitre/hour) 1 hour
Secondary Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion Machine flow (millilitre/hour) 1 hour
Secondary Machine pressure during controlled oxygenated rewarming Machine pressure ((millimetre Hg)) 1 hour
Secondary Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion Machine pressure ((millimetre Hg)) 1 hour
Secondary Machine Fraction of oxygen during controlled oxygenated rewarming Machine fraction of oxygen (%) 1 hour
Secondary Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion Machine fraction of oxygen (%) 1 hour
Secondary Machine Resistance during controlled oxygenated rewarming Machine Resistance (millilitre/minute/millimetre Hg) 1 hour
Secondary Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion Machine Resistance (millilitre/minute/millimetre Hg) 1 hour
Secondary Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion flow (millilitre/hour) 2 hours
Secondary Machine flow during normothermic machine perfusion Machine flow during normothermic machine perfusion (millilitre/hour) 4 hours
Secondary Machine flow during normothermic machine perfusion Machine flow during normothermic machine perfusion (millilitre/hour) 2.5 hours
Secondary Machine pressure during normothermic machine perfusion Machine pressure (millimetre Hg) 4 hours
Secondary Machine pressure during normothermic machine perfusion Machine pressure (millimetre Hg) 2.5 hours
Secondary Machine Fraction of oxygen during normothermic machine perfusion Machine fraction of oxygen (%) 4 hours
Secondary Machine Fraction of oxygen during normothermic machine perfusion Machine fraction of oxygen (%) 2.5 hours
Secondary Machine Resistance during normothermic machine perfusion Machine Resistance (millilitre/minute/millimetre Hg) 4 hours
Secondary Machine Resistance during normothermic machine perfusion Machine Resistance (millilitre/minute/millimetre Hg) 2.5 hours
Secondary Total preservation time Total preservation time (machine perfusion time) 48 hours
Secondary Alanine amino transferase in perfusate during machine perfusion Alanine amino transferase in perfusate during machine perfusion (U/Litre) 24 hours
Secondary Aspartate amino transferase in perfusate during machine perfusion Aspartate amino transferase in perfusate during machine perfusion (U/Litre) 24 hours
Secondary Alkaline phosphatase in perfusate during machine perfusion Aspartate amino transferase in perfusate during machine perfusion (U/Litre) 24 hours
Secondary Gamma-glutamyl transferase in perfusate during machine perfusion Gamma-glutamyl transferase in perfusate during machine perfusion (U/Litre) 24 hours
Secondary Urea in perfusate during machine perfusion Urea in perfusate during machine perfusion (millimol/Litre) 24 hours
Secondary Bilirubin in perfusate during machine perfusion Bilirubin in perfusate during machine perfusion (micromol/Litre) 24 hours
Secondary Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion Different cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion 24 hours
Secondary Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion Different cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion 24 hours
Secondary Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion Different cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion 24 hours
Secondary Histopathology - liver tissue. Mitochondrial function Histological analysis of parenchymal biopsies which are assessed for mitochondrial function. During machine perfusion - 24 hours
Secondary Histopathology - bile duct. Mitochondrial function Histological analysis of bile duct biopsies which are assessed for mitochondrial function. During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. Perfusion/reperfusion injury Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury During machine perfusion - 24 hours
Secondary Histopathology - bile duct. Perfusion/reperfusion injury Histological analysis of bile duct biopsies which are assessed for perfusion/reperfusion injury During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. Cell death Histological analysis of parenchymal biopsies which are assessed for cell death During machine perfusion - 24 hours
Secondary Histopathology - bile duct. Cell death Histological analysis of bile duct biopsies which are assessed for cell death During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. Inflammation Histological analysis of parenchymal biopsies which are assessed for inflammation During machine perfusion - 24 hours
Secondary Histopathology - bile duct. Inflammation Histological analysis of bile duct biopsies which are assessed for inflammation During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. Metabolomics Histological analysis of parenchymal biopsies which are assessed for metabolomics During machine perfusion - 24 hours
Secondary Histopathology - bileduct. Metabolomics Histological analysis of bile duct biopsies which are assessed for metabolomics During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. Lipidomics Histological analysis of parenchymal biopsies which are assessed for lipidomics During machine perfusion - 24 hours
Secondary Histopathology - bile duct. Lipidomics Histological analysis of bile duct biopsies which are assessed for lipidomics During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. RNA sequencing Histological analysis of parenchymal biopsies which are assessed for RNA sequencing During machine perfusion - 24 hours
Secondary Histopathology - bile duct. RNA sequencing Histological analysis of bile duct biopsies which are assessed for RNA sequencing During machine perfusion - 24 hours
Secondary Histopathology - liver tissue. Endothelium properties Histological analysis of parenchymal biopsies which are assessed for endothelium properties During machine perfusion - 24 hours
Secondary Histopathology - bile duct. Endothelium properties Histological analysis of bile duct biopsies which are assessed for endothelium properties During machine perfusion - 24 hours
Secondary International normalized ratio on postoperative day 7 Blood sample from recipient: International normalized ratio on postoperative day 7 7 postoperative day
Secondary Alanine amino transferase postoperative day 0 Alanine amino transferase postoperative day 0 in the donated recipients (U/Litre) Postoperative day 0
Secondary Aspartate amino transferase postoperative day 0 Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre) Postoperative day 0
Secondary Alkaline phosphatase postoperative day 0 Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre) Postoperative day 0
Secondary Gamma-glutamyl transferase postoperative day 0 Gamma-glutamyl transferase postoperative day 0 in the donated recipients (U/Litre) Postoperative day 0
Secondary Urea postoperative day 0 Urea postoperative day 0 in the donated recipients (millimol/Litre) Postoperative day 0
Secondary Bilirubin postoperative day 0 Bilirubin postoperative day 0 in the donated recipients (micromol/Litre) Postoperative day 0
Secondary Bilirubin postoperative day 1 Bilirubin postoperative day 1 in the donated recipients (micromol/Litre) Postoperative day 1
Secondary Bilirubin postoperative day 2 Bilirubin postoperative day 2 in the donated recipients (micromol/Litre) Postoperative day 2
Secondary Bilirubin postoperative day 3 Bilirubin postoperative day 3 in the donated recipients (micromol/Litre) Postoperative day 3
Secondary Bilirubin postoperative day 4 Bilirubin postoperative day 4 in the donated recipients (micromol/Litre) Postoperative day 4
Secondary Bilirubin postoperative day 5 Bilirubin postoperative day 5 in the donated recipients (micromol/Litre) Postoperative day 5
Secondary Bilirubin postoperative day 6 Bilirubin postoperative day 6 in the donated recipients (micromol/Litre) Postoperative day 6
Secondary Bilirubin postoperative day 7 Bilirubin postoperative day 7 in the donated recipients (micromol/Litre) Postoperative day 7
Secondary Urea postoperative day 1 Urea postoperative day 1 in the donated recipients (millimol/Litre) Postoperative day 1
Secondary Urea postoperative day 2 Urea postoperative day 2 in the donated recipients (millimol/Litre) Postoperative day 2
Secondary Urea postoperative day 3 Urea postoperative day 3 in the donated recipients (millimol/Litre) Postoperative day 3
Secondary Urea postoperative day 4 Urea postoperative day 4 in the donated recipients (millimol/Litre) Postoperative day 4
Secondary Urea postoperative day 5 Urea postoperative day 5 in the donated recipients (millimol/Litre) Postoperative day 5
Secondary Urea postoperative day 6 Urea postoperative day 6 in the donated recipients (millimol/Litre) Postoperative day 6
Secondary Urea postoperative day 7 Urea postoperative day 7 in the donated recipients (millimol/Litre) Postoperative day 7
Secondary Aspartate amino transferase postoperative day 1 Aspartate amino transferase postoperative day 1 in the donated recipients (U/Litre) Postoperative day 1
Secondary Alkaline phosphatase postoperative day 1 Alkaline phosphatase postoperative day 1 in the donated recipients (U/Litre) Postoperative day 1
Secondary Gamma-glutamyl transferase postoperative day 1 Gamma-glutamyl transferase postoperative day 1 in the donated recipients (U/Litre) Postoperative day 1
Secondary Alanine amino transferase postoperative day 2 Alanine amino transferase postoperative day 2 in the donated recipients (U/Litre) Postoperative day 2
Secondary Aspartate amino transferase postoperative day 2 Aspartate amino transferase postoperative day 2 in the donated recipients (U/Litre) Postoperative day 2
Secondary Alkaline phosphatase postoperative day 2 Alkaline phosphatase postoperative day 2 in the donated recipients (U/Litre) Postoperative day 2
Secondary Gamma-glutamyl transferase postoperative day 2 Gamma-glutamyl transferase postoperative day 2 in the donated recipients (U/Litre) Postoperative day 2
Secondary Alanine amino transferase postoperative day 3 Alanine amino transferase postoperative day 3 in the donated recipients (U/Litre) Postoperative day 3
Secondary Aspartate amino transferase postoperative day 3 Aspartate amino transferase postoperative day 3 in the donated recipients (U/Litre) Postoperative day 3
Secondary Alkaline phosphatase postoperative day 3 Alkaline phosphatase postoperative day 3 in the donated recipients (U/Litre) Postoperative day 3
Secondary Gamma-glutamyl transferase postoperative day 3 Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre) Postoperative day 3
Secondary Alanine amino transferase postoperative day 4 Alanine amino transferase postoperative day 4 in the donated recipients (U/Litre) Postoperative day 4
Secondary Aspartate amino transferase postoperative day 4 Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre) Postoperative day 4
Secondary Alkaline phosphatase postoperative day 4 Alkaline phosphatase postoperative day 4 in the donated recipients (U/Litre) Postoperative day 4
Secondary Gamma-glutamyl transferase postoperative day 4 Gamma-glutamyl transferase postoperative day 4 in the donated recipients (U/Litre) Postoperative day 4
Secondary Alanine amino transferase postoperative day 5 Alanine amino transferase postoperative day 5 in the donated recipients (U/Litre) Postoperative day 5
Secondary Aspartate amino transferase postoperative day 5 Aspartate amino transferase postoperative day 5 in the donated recipients (U/Litre) Postoperative day 5
Secondary Alkaline phosphatase postoperative day 5 Alkaline phosphatase postoperative day 5 in the donated recipients (U/Litre) Postoperative day 5
Secondary Gamma-glutamyl transferase postoperative day 5 Gamma-glutamyl transferase postoperative day 5 in the donated recipients (U/Litre) Postoperative day 5
Secondary Alanine amino transferase postoperative day 6 Alanine amino transferase postoperative day 6 in the donated recipients (U/Litre) Postoperative day 6
Secondary Aspartate amino transferase postoperative day 6 Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre) Postoperative day 6
Secondary Alkaline phosphatase postoperative day 6 Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre) Postoperative day 6
Secondary Gamma-glutamyl transferase postoperative day 6 Gamma-glutamyl transferase postoperative day 6 in the donated recipients (U/Litre) Postoperative day 6
Secondary Alanine amino transferase postoperative day 7 Alanine amino transferase postoperative day 7 in the donated recipients (U/Litre) Postoperative day 7
Secondary Aspartate amino transferase postoperative day 7 Aspartate amino transferase postoperative day 7 in the donated recipients (U/Litre) Postoperative day 7
Secondary Alkaline phosphatase postoperative day 7 Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre) Postoperative day 7
Secondary Gamma-glutamyl transferase postoperative day 7 Gamma-glutamyl transferase postoperative day 7 in the donated recipients (U/Litre) Postoperative day 7
Secondary Alanine amino transferase postoperative month 1 Alanine amino transferase postoperative month 1 in the donated recipients (U/Litre) 1 month after surgery
Secondary Aspartate amino transferase postoperative month 1 Aspartate amino transferase postoperative month 1 in the donated recipients (U/Litre) 1 month after surgery
Secondary Alkaline phosphatase postoperative month 1 Alkaline phosphatase postoperative month 1 in the donated recipients (U/Litre) 1 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 1 Gamma-glutamyl transferase postoperative month 1 in the donated recipients (U/Litre) 1 month after surgery
Secondary Urea postoperative month 1 Urea postoperative month 1 in the donated recipients (millimol/Litre) 1 month after surgery
Secondary Bilirubin postoperative month 1 Bilirubin postoperative month 1 in the donated recipients (micromol/Litre) 1 month after surgery
Secondary Bilirubin postoperative month 2 Bilirubin postoperative month 2 in the donated recipients (micromol/Litre) 2 month after surgery
Secondary Bilirubin postoperative month 3 Bilirubin postoperative month 3 in the donated recipients (micromol/Litre) 3 month after surgery
Secondary Bilirubin postoperative month 4 Bilirubin postoperative month 4 in the donated recipients (micromol/Litre) 4 month after surgery
Secondary Bilirubin postoperative month 5 Bilirubin postoperative month 5 in the donated recipients (micromol/Litre) 5 month after surgery
Secondary Bilirubin postoperative month 6 Bilirubin postoperative month 6 in the donated recipients (micromol/Litre) 6 month after surgery
Secondary Bilirubin postoperative month 7 Bilirubin postoperative month 7 in the donated recipients (micromol/Litre) 7 month after surgery
Secondary Bilirubin postoperative month 8 Bilirubin postoperative month 8 in the donated recipients (micromol/Litre) 8 month after surgery
Secondary Bilirubin postoperative month 9 Bilirubin postoperative month 9 in the donated recipients (micromol/Litre) 9 month after surgery
Secondary Bilirubin postoperative month 10 Bilirubin postoperative month 10 in the donated recipients (micromol/Litre) 10 month after surgery
Secondary Bilirubin postoperative month 11 Bilirubin postoperative month 11 in the donated recipients (micromol/Litre) 11 month after surgery
Secondary Bilirubin postoperative month 12 Bilirubin postoperative month 12 in the donated recipients (micromol/Litre) 12 month after surgery
Secondary Urea postoperative month 2 Urea postoperative month 2 in the donated recipients (millimol/Litre) 2 month after surgery
Secondary Urea postoperative month 3 Urea postoperative month 3 in the donated recipients (millimol/Litre) 3 month after surgery
Secondary Urea postoperative month 4 Urea postoperative month 4 in the donated recipients (millimol/Litre) 4 month after surgery
Secondary Urea postoperative month 5 Urea postoperative month 5 in the donated recipients (millimol/Litre) 5 month after surgery
Secondary Urea postoperative month 6 Urea postoperative month 6 in the donated recipients (millimol/Litre) 6 month after surgery
Secondary Urea postoperative month 7 Urea postoperative month 7 in the donated recipients (millimol/Litre) 7 month after surgery
Secondary Urea postoperative month 8 Urea postoperative month 8 in the donated recipients (millimol/Litre) 8 month after surgery
Secondary Urea postoperative month 9 Urea postoperative month 9 in the donated recipients (millimol/Litre) 9 month after surgery
Secondary Urea postoperative month 10 Urea postoperative month 10 in the donated recipients (millimol/Litre) 10 month after surgery
Secondary Urea postoperative month 11 Urea postoperative month 11 in the donated recipients (millimol/Litre) 11 month after surgery
Secondary Urea postoperative month 12 Urea postoperative month 12 in the donated recipients (millimol/Litre) 12 month after surgery
Secondary Alanine amino transferase postoperative month 2 Alanine amino transferase postoperative month 2 in the donated recipients (U/Litre) 2 month after surgery
Secondary Aspartate amino transferase postoperative month 2 Aspartate amino transferase postoperative month 2 in the donated recipients (U/Litre) 2 month after surgery
Secondary Alkaline phosphatase postoperative month 2 Alkaline phosphatase postoperative month 2 in the donated recipients (U/Litre) 2 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 2 Gamma-glutamyl transferase postoperative month 2 in the donated recipients (U/Litre) 2 month after surgery
Secondary Alanine amino transferase postoperative month 3 Alanine amino transferase postoperative month 3 in the donated recipients (U/Litre) 3 month after surgery
Secondary Aspartate amino transferase postoperative month 3 Aspartate amino transferase postoperative month 3 in the donated recipients (U/Litre) 3 month after surgery
Secondary Alkaline phosphatase postoperative month 3 Alkaline phosphatase postoperative month 3 in the donated recipients (U/Litre) 3 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 3 Gamma-glutamyl transferase postoperative month 3 in the donated recipients (U/Litre) 3 month after surgery
Secondary Alanine amino transferase postoperative month 4 Alanine amino transferase postoperative month 4 in the donated recipients (U/Litre) 4 month after surgery
Secondary Aspartate amino transferase postoperative month 4 Aspartate amino transferase postoperative month 4 in the donated recipients (U/Litre) 4 month after surgery
Secondary Alkaline phosphatase postoperative month 4 Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre) 4 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 4 Gamma-glutamyl transferase postoperative month 4 in the donated recipients (U/Litre) 4 month after surgery
Secondary Alanine amino transferase postoperative month 5 Alanine amino transferase postoperative month 5 in the donated recipients (U/Litre) 5 month after surgery
Secondary Aspartate amino transferase postoperative month 5 Aspartate amino transferase postoperative month 5 in the donated recipients (U/Litre) 5 month after surgery
Secondary Alkaline phosphatase postoperative month 5 Alkaline phosphatase postoperative month 5 in the donated recipients (U/Litre) 5 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 5 Gamma-glutamyl transferase postoperative month 5 in the donated recipients (U/Litre) 5 month after surgery
Secondary Alanine amino transferase postoperative month 6 Alanine amino transferase postoperative month 6 in the donated recipients (U/Litre) 6 month after surgery
Secondary Aspartate amino transferase postoperative month 6 Aspartate amino transferase postoperative month 6 in the donated recipients (U/Litre) 6 month after surgery
Secondary Alkaline phosphatase postoperative month 6 Alkaline phosphatase postoperative month 6 in the donated recipients (U/Litre) 6 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 6 Gamma-glutamyl transferase postoperative month 6 in the donated recipients (U/Litre) 6 month after surgery
Secondary Alanine amino transferase postoperative month 7 Alanine amino transferase postoperative month 7 in the donated recipients (U/Litre) 7 month after surgery
Secondary Aspartate amino transferase postoperative month 7 Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre) 7 month after surgery
Secondary Alkaline phosphatase postoperative month 7 Alkaline phosphatase postoperative month 7 in the donated recipients (U/Litre) 7 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 7 Gamma-glutamyl transferase postoperative month 7 in the donated recipients (U/Litre) 7 month after surgery
Secondary Alanine amino transferase postoperative month 8 Alanine amino transferase postoperative month 8 in the donated recipients (U/Litre) 8 month after surgery
Secondary Aspartate amino transferase postoperative month 8 Aspartate amino transferase postoperative month 8 in the donated recipients (U/Litre) 8 month after surgery
Secondary Alkaline phosphatase postoperative month 8 Alkaline phosphatase postoperative month 8 in the donated recipients (U/Litre) 8 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 8 Gamma-glutamyl transferase postoperative month 8 in the donated recipients (U/Litre) 8 month after surgery
Secondary Alanine amino transferase postoperative month 9 Alanine amino transferase postoperative month 9 in the donated recipients (U/Litre) 9 month after surgery
Secondary Aspartate amino transferase postoperative month 9 Aspartate amino transferase postoperative month 9 in the donated recipients (U/Litre) 9 month after surgery
Secondary Alkaline phosphatase postoperative month 9 Alkaline phosphatase postoperative month 9 in the donated recipients (U/Litre) 9 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 9 Gamma-glutamyl transferase postoperative month 9 in the donated recipients (U/Litre) 9 month after surgery
Secondary Alanine amino transferase postoperative month 10 Alanine amino transferase postoperative month 10 in the donated recipients (U/Litre) 10 month after surgery
Secondary Aspartate amino transferase postoperative month 10 Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre) 10 month after surgery
Secondary Alkaline phosphatase postoperative month 10 Alkaline phosphatase postoperative month 10 in the donated recipients (U/Litre) 10 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 10 Gamma-glutamyl transferase postoperative month 10 in the donated recipients (U/Litre) 10 month after surgery
Secondary Alanine amino transferase postoperative month 11 Alanine amino transferase postoperative month 11 in the donated recipients (U/Litre) 11 month after surgery
Secondary Aspartate amino transferase postoperative month 11 Aspartate amino transferase postoperative month 11 in the donated recipients (U/Litre) 11 month after surgery
Secondary Alkaline phosphatase postoperative month 11 Alkaline phosphatase postoperative month 11 in the donated recipients (U/Litre) 11 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 11 Gamma-glutamyl transferase postoperative month 11 in the donated recipients (U/Litre) 11 month after surgery
Secondary Alanine amino transferase postoperative month 12 Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre) 12 month after surgery
Secondary Aspartate amino transferase postoperative month 12 Aspartate amino transferase postoperative month 12 in the donated recipients (U/Litre) 12 month after surgery
Secondary Alkaline phosphatase postoperative month 12 Alkaline phosphatase postoperative month 12 in the donated recipients (U/Litre) 12 month after surgery
Secondary Gamma-glutamyl transferase postoperative month 12 Gamma-glutamyl transferase postoperative month 12 in the donated recipients (U/Litre) 12 month after surgery
Secondary Postoperative microdialysis levels of lactate Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days 14 days
Secondary Postoperative microdialysis levels of pyruvate Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days 14 days
Secondary Postoperative microdialysis levels of glycerol Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days 14 days
Secondary Postoperative microdialysis levels of glucose Postoperative microdialysis levels of glucose in transplanted livers the first 14 postoperative days 14 days
Secondary Systolic blood pressure Systolic blood pressure (millimeter Hg) From 5 min before reperfusion, up to 20 minutes after reperfusion
Secondary Diastolic blood pressure Diastolic blood pressure (millimeter Hg) From 5 min before reperfusion, up to 20 minutes after reperfusion
Secondary Heart rate Heart rate (Beats/minute) From 5 min before reperfusion, up to 20 minutes after reperfusion
Secondary Vasopressor dosage Vasopressor dosage (microgram/kilogram/minutes) From 5 min before reperfusion, up to 20 minutes after reperfusion
Secondary Patient survival Patient survival (days) Through study completion, an average of 12 months
Secondary Graft survival Graft (censored and uncensored for patient death) survival (days) Through study completion, an average of 12 months
Secondary Number of deaths Number of deaths first 7 days after transplantation 7 days after transplantation
Secondary Number of retransplantation Number of retransplantation first 7 days after transplantation 7 days after transplantation
Secondary Incidens of new onset diabetes after transplantation 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). Through study completion, an average of 12 months
Secondary Estimated glomerular filtration rate - Renal function Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease equation. Through study completion, an average of 12 months
Secondary The incidence of symptomatic Non-anastomotic Biliary Strictures The incidence of symptomatic non-anastomotic biliary strictures 6 months
Secondary The incidence of asymptomatic Non-anastomotic Biliary Strictures The incidence of asymptomatic non-anastomotic biliary strictures 6 months
Secondary The incidence of asymptomatic Non-anastomotic Biliary Strictures The incidence of asymptomatic non-anastomotic biliary strictures 12 months
Secondary The incidence of symptomatic Non-anastomotic Biliary Strictures The incidence of symptomatic non-anastomotic biliary strictures 12 months
Secondary The severity of Non-anastomotic Biliary Strictures The severity of Non-anastomotic Biliary Strictures based on a scoring system described by Buis et. al (mild, moderate, or severe) Through study completion, an average of 12 months
Secondary The location of Non-anastomotic Biliary Strictures The location of Non-anastomotic Biliary Strictures is assessed by images of the magnetic resonance cholangiopancreatography Through study completion, an average of 12 months
Secondary The incidence of infections The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment Through study completion, an average of 12 months
Secondary Lactate level in microdialysate from liver tissue - 4 hours Microdialysis lactate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours Glycerol level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours Glucose level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers. 4 hours
Secondary Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hours
Secondary Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers. 1 hour
Secondary Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hour
Secondary Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers. 2 hour
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