Clinical trial NCT05951231: Liver Transplantation After ex Vivo Liver Perfusion
Official title: Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Transplant; Failure, Liver
Transplant Dysfunction
Transplant; Complication, Rejection
Transplant
Liver Metastases
Liver Cancer
Keywords: Liver
Transplantation
Perfusion
Dual-end-ischemic Hypothermic Oxygenated Perfusion
Normothermic Machine Perfusion
Controlled Oxygenated Rewarming
Microdialysis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2023-07-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, prospective, open, observational study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
Secondary outcomes:
measure: Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
timeFrame: 2.5 hours
measure: Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Bile gases pH - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases pH - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases Lactate - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases Lactate - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases Glucose - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases Glucose - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases O2 - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases CO2 - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases HCO3 - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases base excess (BE) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 4 hours
measure: Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 4 hours
measure: Ischemia/reperfusion injury - before machine perfusion
timeFrame: 1 minute
measure: Ischemia/reperfusion damage - before machine perfusion
timeFrame: 1 minute
measure: Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases BE - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases SO2 - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases Hb - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases sodium (Na) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases Na - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases potassium (K) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases K - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion
timeFrame: 4 hours
measure: Bile gases Ca - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion
timeFrame: 2.5 hours
measure: Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
timeFrame: 2 hours
measure: Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hour
measure: Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion
timeFrame: 1 hours
measure: Perfusate gas Ca - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas pH - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas SO2 - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas O2 - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas CO2 - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas K - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas Na - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas BE - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas HCO3 - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas hemoglobin - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas lactate - during machine perfusion
timeFrame: 24 hours
measure: Perfusate gas glucose - during machine perfusion
timeFrame: 24 hours
measure: Postoperative complications
timeFrame: 12 months
measure: Length of stay
timeFrame: 4 months
measure: Machine flow during controlled oxygenated rewarming
timeFrame: 1 hour
measure: Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
timeFrame: 1 hour
measure: Machine pressure during controlled oxygenated rewarming
timeFrame: 1 hour
measure: Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion
timeFrame: 1 hour
measure: Machine Fraction of oxygen during controlled oxygenated rewarming
timeFrame: 1 hour
measure: Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion
timeFrame: 1 hour
measure: Machine Resistance during controlled oxygenated rewarming
timeFrame: 1 hour
measure: Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion
timeFrame: 1 hour
measure: Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
timeFrame: 2 hours
measure: Machine flow during normothermic machine perfusion
timeFrame: 4 hours
measure: Machine flow during normothermic machine perfusion
timeFrame: 2.5 hours
measure: Machine pressure during normothermic machine perfusion
timeFrame: 4 hours
measure: Machine pressure during normothermic machine perfusion
timeFrame: 2.5 hours
measure: Machine Fraction of oxygen during normothermic machine perfusion
timeFrame: 4 hours
measure: Machine Fraction of oxygen during normothermic machine perfusion
timeFrame: 2.5 hours
measure: Machine Resistance during normothermic machine perfusion
timeFrame: 4 hours
measure: Machine Resistance during normothermic machine perfusion
timeFrame: 2.5 hours
measure: Total preservation time
timeFrame: 48 hours
measure: Alanine amino transferase in perfusate during machine perfusion
timeFrame: 24 hours
measure: Aspartate amino transferase in perfusate during machine perfusion
timeFrame: 24 hours
measure: Alkaline phosphatase in perfusate during machine perfusion
timeFrame: 24 hours
measure: Gamma-glutamyl transferase in perfusate during machine perfusion
timeFrame: 24 hours
measure: Urea in perfusate during machine perfusion
timeFrame: 24 hours
measure: Bilirubin in perfusate during machine perfusion
timeFrame: 24 hours
measure: Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
timeFrame: 24 hours
measure: Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
timeFrame: 24 hours
measure: Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
timeFrame: 24 hours
measure: Histopathology - liver tissue. Mitochondrial function
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. Mitochondrial function
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. Perfusion/reperfusion injury
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. Perfusion/reperfusion injury
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. Cell death
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. Cell death
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. Inflammation
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. Inflammation
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. Metabolomics
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bileduct. Metabolomics
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. Lipidomics
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. Lipidomics
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. RNA sequencing
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. RNA sequencing
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - liver tissue. Endothelium properties
timeFrame: During machine perfusion - 24 hours
measure: Histopathology - bile duct. Endothelium properties
timeFrame: During machine perfusion - 24 hours
measure: International normalized ratio on postoperative day 7
timeFrame: 7 postoperative day
measure: Alanine amino transferase postoperative day 0
timeFrame: Postoperative day 0
measure: Aspartate amino transferase postoperative day 0
timeFrame: Postoperative day 0
measure: Alkaline phosphatase postoperative day 0
timeFrame: Postoperative day 0
measure: Gamma-glutamyl transferase postoperative day 0
timeFrame: Postoperative day 0
measure: Urea postoperative day 0
timeFrame: Postoperative day 0
measure: Bilirubin postoperative day 0
timeFrame: Postoperative day 0
measure: Bilirubin postoperative day 1
timeFrame: Postoperative day 1
measure: Bilirubin postoperative day 2
timeFrame: Postoperative day 2
measure: Bilirubin postoperative day 3
timeFrame: Postoperative day 3
measure: Bilirubin postoperative day 4
timeFrame: Postoperative day 4
measure: Bilirubin postoperative day 5
timeFrame: Postoperative day 5
measure: Bilirubin postoperative day 6
timeFrame: Postoperative day 6
measure: Bilirubin postoperative day 7
timeFrame: Postoperative day 7
measure: Urea postoperative day 1
timeFrame: Postoperative day 1
measure: Urea postoperative day 2
timeFrame: Postoperative day 2
measure: Urea postoperative day 3
timeFrame: Postoperative day 3
measure: Urea postoperative day 4
timeFrame: Postoperative day 4
measure: Urea postoperative day 5
timeFrame: Postoperative day 5
measure: Urea postoperative day 6
timeFrame: Postoperative day 6
measure: Urea postoperative day 7
timeFrame: Postoperative day 7
measure: Aspartate amino transferase postoperative day 1
timeFrame: Postoperative day 1
measure: Alkaline phosphatase postoperative day 1
timeFrame: Postoperative day 1
measure: Gamma-glutamyl transferase postoperative day 1
timeFrame: Postoperative day 1
measure: Alanine amino transferase postoperative day 2
timeFrame: Postoperative day 2
measure: Aspartate amino transferase postoperative day 2
timeFrame: Postoperative day 2
measure: Alkaline phosphatase postoperative day 2
timeFrame: Postoperative day 2
measure: Gamma-glutamyl transferase postoperative day 2
timeFrame: Postoperative day 2
measure: Alanine amino transferase postoperative day 3
timeFrame: Postoperative day 3
measure: Aspartate amino transferase postoperative day 3
timeFrame: Postoperative day 3
measure: Alkaline phosphatase postoperative day 3
timeFrame: Postoperative day 3
measure: Gamma-glutamyl transferase postoperative day 3
timeFrame: Postoperative day 3
measure: Alanine amino transferase postoperative day 4
timeFrame: Postoperative day 4
measure: Aspartate amino transferase postoperative day 4
timeFrame: Postoperative day 4
measure: Alkaline phosphatase postoperative day 4
timeFrame: Postoperative day 4
measure: Gamma-glutamyl transferase postoperative day 4
timeFrame: Postoperative day 4
measure: Alanine amino transferase postoperative day 5
timeFrame: Postoperative day 5
measure: Aspartate amino transferase postoperative day 5
timeFrame: Postoperative day 5
measure: Alkaline phosphatase postoperative day 5
timeFrame: Postoperative day 5
measure: Gamma-glutamyl transferase postoperative day 5
timeFrame: Postoperative day 5
measure: Alanine amino transferase postoperative day 6
timeFrame: Postoperative day 6
measure: Aspartate amino transferase postoperative day 6
timeFrame: Postoperative day 6
measure: Alkaline phosphatase postoperative day 6
timeFrame: Postoperative day 6
measure: Gamma-glutamyl transferase postoperative day 6
timeFrame: Postoperative day 6
measure: Alanine amino transferase postoperative day 7
timeFrame: Postoperative day 7
measure: Aspartate amino transferase postoperative day 7
timeFrame: Postoperative day 7
measure: Alkaline phosphatase postoperative day 7
timeFrame: Postoperative day 7
measure: Gamma-glutamyl transferase postoperative day 7
timeFrame: Postoperative day 7
measure: Alanine amino transferase postoperative month 1
timeFrame: 1 month after surgery
measure: Aspartate amino transferase postoperative month 1
timeFrame: 1 month after surgery
measure: Alkaline phosphatase postoperative month 1
timeFrame: 1 month after surgery
measure: Gamma-glutamyl transferase postoperative month 1
timeFrame: 1 month after surgery
measure: Urea postoperative month 1
timeFrame: 1 month after surgery
measure: Bilirubin postoperative month 1
timeFrame: 1 month after surgery
measure: Bilirubin postoperative month 2
timeFrame: 2 month after surgery
measure: Bilirubin postoperative month 3
timeFrame: 3 month after surgery
measure: Bilirubin postoperative month 4
timeFrame: 4 month after surgery
measure: Bilirubin postoperative month 5
timeFrame: 5 month after surgery
measure: Bilirubin postoperative month 6
timeFrame: 6 month after surgery
measure: Bilirubin postoperative month 7
timeFrame: 7 month after surgery
measure: Bilirubin postoperative month 8
timeFrame: 8 month after surgery
measure: Bilirubin postoperative month 9
timeFrame: 9 month after surgery
measure: Bilirubin postoperative month 10
timeFrame: 10 month after surgery
measure: Bilirubin postoperative month 11
timeFrame: 11 month after surgery
measure: Bilirubin postoperative month 12
timeFrame: 12 month after surgery
measure: Urea postoperative month 2
timeFrame: 2 month after surgery
measure: Urea postoperative month 3
timeFrame: 3 month after surgery
measure: Urea postoperative month 4
timeFrame: 4 month after surgery
measure: Urea postoperative month 5
timeFrame: 5 month after surgery
measure: Urea postoperative month 6
timeFrame: 6 month after surgery
measure: Urea postoperative month 7
timeFrame: 7 month after surgery
measure: Urea postoperative month 8
timeFrame: 8 month after surgery
measure: Urea postoperative month 9
timeFrame: 9 month after surgery
measure: Urea postoperative month 10
timeFrame: 10 month after surgery
measure: Urea postoperative month 11
timeFrame: 11 month after surgery
measure: Urea postoperative month 12
timeFrame: 12 month after surgery
measure: Alanine amino transferase postoperative month 2
timeFrame: 2 month after surgery
measure: Aspartate amino transferase postoperative month 2
timeFrame: 2 month after surgery
measure: Alkaline phosphatase postoperative month 2
timeFrame: 2 month after surgery
measure: Gamma-glutamyl transferase postoperative month 2
timeFrame: 2 month after surgery
measure: Alanine amino transferase postoperative month 3
timeFrame: 3 month after surgery
measure: Aspartate amino transferase postoperative month 3
timeFrame: 3 month after surgery
measure: Alkaline phosphatase postoperative month 3
timeFrame: 3 month after surgery
measure: Gamma-glutamyl transferase postoperative month 3
timeFrame: 3 month after surgery
measure: Alanine amino transferase postoperative month 4
timeFrame: 4 month after surgery
measure: Aspartate amino transferase postoperative month 4
timeFrame: 4 month after surgery
measure: Alkaline phosphatase postoperative month 4
timeFrame: 4 month after surgery
measure: Gamma-glutamyl transferase postoperative month 4
timeFrame: 4 month after surgery
measure: Alanine amino transferase postoperative month 5
timeFrame: 5 month after surgery
measure: Aspartate amino transferase postoperative month 5
timeFrame: 5 month after surgery
measure: Alkaline phosphatase postoperative month 5
timeFrame: 5 month after surgery
measure: Gamma-glutamyl transferase postoperative month 5
timeFrame: 5 month after surgery
measure: Alanine amino transferase postoperative month 6
timeFrame: 6 month after surgery
measure: Aspartate amino transferase postoperative month 6
timeFrame: 6 month after surgery
measure: Alkaline phosphatase postoperative month 6
timeFrame: 6 month after surgery
measure: Gamma-glutamyl transferase postoperative month 6
timeFrame: 6 month after surgery
measure: Alanine amino transferase postoperative month 7
timeFrame: 7 month after surgery
measure: Aspartate amino transferase postoperative month 7
timeFrame: 7 month after surgery
measure: Alkaline phosphatase postoperative month 7
timeFrame: 7 month after surgery
measure: Gamma-glutamyl transferase postoperative month 7
timeFrame: 7 month after surgery
measure: Alanine amino transferase postoperative month 8
timeFrame: 8 month after surgery
measure: Aspartate amino transferase postoperative month 8
timeFrame: 8 month after surgery
measure: Alkaline phosphatase postoperative month 8
timeFrame: 8 month after surgery
measure: Gamma-glutamyl transferase postoperative month 8
timeFrame: 8 month after surgery
measure: Alanine amino transferase postoperative month 9
timeFrame: 9 month after surgery
measure: Aspartate amino transferase postoperative month 9
timeFrame: 9 month after surgery
measure: Alkaline phosphatase postoperative month 9
timeFrame: 9 month after surgery
measure: Gamma-glutamyl transferase postoperative month 9
timeFrame: 9 month after surgery
measure: Alanine amino transferase postoperative month 10
timeFrame: 10 month after surgery
measure: Aspartate amino transferase postoperative month 10
timeFrame: 10 month after surgery
measure: Alkaline phosphatase postoperative month 10
timeFrame: 10 month after surgery
measure: Gamma-glutamyl transferase postoperative month 10
timeFrame: 10 month after surgery
measure: Alanine amino transferase postoperative month 11
timeFrame: 11 month after surgery
measure: Aspartate amino transferase postoperative month 11
timeFrame: 11 month after surgery
measure: Alkaline phosphatase postoperative month 11
timeFrame: 11 month after surgery
measure: Gamma-glutamyl transferase postoperative month 11
timeFrame: 11 month after surgery
measure: Alanine amino transferase postoperative month 12
timeFrame: 12 month after surgery
measure: Aspartate amino transferase postoperative month 12
timeFrame: 12 month after surgery
measure: Alkaline phosphatase postoperative month 12
timeFrame: 12 month after surgery
measure: Gamma-glutamyl transferase postoperative month 12
timeFrame: 12 month after surgery
measure: Postoperative microdialysis levels of lactate
timeFrame: 14 days
measure: Postoperative microdialysis levels of pyruvate
timeFrame: 14 days
measure: Postoperative microdialysis levels of glycerol
timeFrame: 14 days
measure: Postoperative microdialysis levels of glucose
timeFrame: 14 days
measure: Systolic blood pressure
timeFrame: From 5 min before reperfusion, up to 20 minutes after reperfusion
measure: Diastolic blood pressure
timeFrame: From 5 min before reperfusion, up to 20 minutes after reperfusion
measure: Heart rate
timeFrame: From 5 min before reperfusion, up to 20 minutes after reperfusion
measure: Vasopressor dosage
timeFrame: From 5 min before reperfusion, up to 20 minutes after reperfusion
measure: Patient survival
timeFrame: Through study completion, an average of 12 months
measure: Graft survival
timeFrame: Through study completion, an average of 12 months
measure: Number of deaths
timeFrame: 7 days after transplantation
measure: Number of retransplantation
timeFrame: 7 days after transplantation
measure: Incidens of new onset diabetes after transplantation
timeFrame: Through study completion, an average of 12 months
measure: Estimated glomerular filtration rate - Renal function
timeFrame: Through study completion, an average of 12 months
measure: The incidence of symptomatic Non-anastomotic Biliary Strictures
timeFrame: 6 months
measure: The incidence of asymptomatic Non-anastomotic Biliary Strictures
timeFrame: 6 months
measure: The incidence of asymptomatic Non-anastomotic Biliary Strictures
timeFrame: 12 months
measure: The incidence of symptomatic Non-anastomotic Biliary Strictures
timeFrame: 12 months
measure: The severity of Non-anastomotic Biliary Strictures
timeFrame: Through study completion, an average of 12 months
measure: The location of Non-anastomotic Biliary Strictures
timeFrame: Through study completion, an average of 12 months
measure: The incidence of infections
timeFrame: Through study completion, an average of 12 months
measure: Lactate level in microdialysate from liver tissue - 4 hours
timeFrame: 4 hours
measure: Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
timeFrame: 4 hours
measure: Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
timeFrame: 2 hours
measure: Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
timeFrame: 1 hour
measure: Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
timeFrame: 2 hour
measure: Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
timeFrame: 2 hour
Other outcomes:
measure: Donor associated variables - age
timeFrame: 1 hour
measure: Donor associated variables - liver steatosis
timeFrame: 1 hour
measure: Donor associated variables - gender
timeFrame: 1 hour
measure: Donor associated variables - Body mass index
timeFrame: 1 hour
measure: Donor associated variables - weight of the liver
timeFrame: 1 hour
measure: Ischemia time - warm
timeFrame: 12 hour
measure: Ischemia time - cold
timeFrame: 12 hour
measure: Donor associated variables - Donor risk index
timeFrame: 1 hour
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Søren E Pischke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: