临床试验/NCT05951231

NCT05951231尚未招募不适用

Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study

Oslo University Hospital0 个研究点目标入组 22 人开始时间: 2024年2月1日最近更新: 2023年11月1日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 22
主要终点: Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

结局指标

主要结局

Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours

时间窗: 4 hours

Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.

次要结局

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

研究者

发起方

Oslo University Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Søren Erik Pischke

Principal investigator

Oslo University Hospital

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