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NCT Number: NCT05951231

Liver Transplantation After ex Vivo Liver Perfusion

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.

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Key information

Conditions

Liver Transplant; Complications Behavior Digestive System Diseases Digestive System Neoplasms Liver Cancer Liver Diseases Liver Metastases Liver Neoplasms Neoplasms Neoplasms by Site Rejection, Psychology Social Behavior Transplant Transplant Dysfunction Transplant; Complication, Rejection Transplant; Failure, Liver

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liver Transplantation

Procedure

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)

Primary outcomes

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

    Time frame: 4 hours

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

Secondary outcomes

  1. Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis lactate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.

  2. Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 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.

  3. Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 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.

  4. Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 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.

  5. Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 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.

  6. Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Microdialysis lactate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  7. Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Microdialysis glycerol level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  8. Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Microdialysis glucose level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  9. Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Microdialysis pyruvate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  10. Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis glucose level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.

  11. Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.

  12. Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis pyruvate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.

  13. Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Microdialysis pyruvate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.

  14. Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis glycerol level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.

  15. Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Microdialysis glycerol level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.

  16. Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Microdialysis lactate level from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.

  17. Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis lactate level from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.

  18. Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Microdialysis glucose levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.

  19. Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis glucose levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.

  20. Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Microdialysis pyruvate levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.

  21. Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Microdialysis pyruvate levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.

  22. Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

    Glycerol levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.

  23. Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours

    Time frame: 2.5 hours

    Glycerol levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.

  24. Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Glycerol levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.

  25. Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Glucose levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.

  26. Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Lactate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.

  27. Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Pyruvate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.

  28. Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 2 hours

    Pyruvate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.

  29. Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 2 hours

    Glycerol levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.

  30. Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 2 hours

    Lactate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.

  31. Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 2 hours

    Glucose levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.

  32. Bile gases pH - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas pH - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  33. Bile gases pH - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas pH - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  34. Bile gases Lactate - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas Lactate - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  35. Bile gases Lactate - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas Lactate - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  36. Bile gases Glucose - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas Glucose - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  37. Bile gases Glucose - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas Glucose - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  38. Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas O2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  39. Bile gases O2 - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas O2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  40. Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas CO2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  41. Bile gases CO2 - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas CO2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  42. Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas HCO3 - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  43. Bile gases HCO3 - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas HCO3 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  44. Bile gases base excess (BE) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas BE - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  45. Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  46. Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  47. Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 4 hours

    Ischemia/reperfusion injury in liver biopsies, graded according to Tian Y et al et al, Liver transplant 2015; nil, mild, moderate, and severe. - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  48. Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 4 hours

    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  49. Ischemia/reperfusion injury - before machine perfusion

    Time frame: 1 minute

    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - before machine perfusion in extended criteria donors livers

  50. Ischemia/reperfusion damage - before machine perfusion

    Time frame: 1 minute

    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - before machine perfusion in extended criteria donors livers

  51. Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 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

  52. Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 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

  53. Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  54. Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  55. Bile gases BE - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas BE - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  56. Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas SO2- 4 hours after normothermic machine perfusion in extended criteria donors livers.

  57. Bile gases SO2 - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas SO2- 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  58. Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas Hb - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  59. Bile gases Hb - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas Hb - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  60. Bile gases sodium (Na) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas Na - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  61. Bile gases Na - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas Na - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  62. Bile gases potassium (K) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas K - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  63. Bile gases K - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas K - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  64. Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion

    Time frame: 4 hours

    Bile gas Ca - 4 hours after normothermic machine perfusion in extended criteria donors livers.

  65. Bile gases Ca - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Bile gas Ca - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  66. Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion

    Time frame: 2.5 hours

    Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.

  67. Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  68. Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  69. Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  70. Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  71. Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  72. Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  73. Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  74. Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  75. Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  76. Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  77. Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  78. Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  79. Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion

    Time frame: 2 hours

    Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  80. Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hour

    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  81. Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  82. Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  83. Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  84. Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  85. Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  86. Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  87. Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  88. Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  89. Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  90. Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  91. Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  92. Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  93. Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion

    Time frame: 1 hours

    Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  94. Perfusate gas Ca - during machine perfusion

    Time frame: 24 hours

    Perfusate gas Ca during machine perfusion in extended criteria donors livers.

  95. Perfusate gas pH - during machine perfusion

    Time frame: 24 hours

    Perfusate gas pH during machine perfusion in extended criteria donors livers.

  96. Perfusate gas SO2 - during machine perfusion

    Time frame: 24 hours

    Perfusate gas SO2 during machine perfusion in extended criteria donors livers.

  97. Perfusate gas O2 - during machine perfusion

    Time frame: 24 hours

    Perfusate gas O2 during machine perfusion in extended criteria donors livers.

  98. Perfusate gas CO2 - during machine perfusion

    Time frame: 24 hours

    Perfusate gas CO2 during machine perfusion in extended criteria donors livers.

  99. Perfusate gas K - during machine perfusion

    Time frame: 24 hours

    Perfusate gas K during machine perfusion in extended criteria donors livers.

  100. Perfusate gas Na - during machine perfusion

    Time frame: 24 hours

    Perfusate gas Na during machine perfusion in extended criteria donors livers.

  101. Perfusate gas BE - during machine perfusion

    Time frame: 24 hours

    Perfusate gas BE during machine perfusion in extended criteria donors livers.

  102. Perfusate gas HCO3 - during machine perfusion

    Time frame: 24 hours

    Perfusate gas HCO3 during machine perfusion in extended criteria donors livers.

  103. Perfusate gas hemoglobin - during machine perfusion

    Time frame: 24 hours

    Perfusate gas hemoglobin during machine perfusion in extended criteria donors livers.

  104. Perfusate gas lactate - during machine perfusion

    Time frame: 24 hours

    Perfusate gas lactate during machine perfusion in extended criteria donors livers.

  105. Perfusate gas glucose - during machine perfusion

    Time frame: 24 hours

    Perfusate gas glucose during machine perfusion in extended criteria donors livers.

  106. Postoperative complications

    Time frame: 12 months

    According to Clavien Dindo Classification

  107. Length of stay

    Time frame: 4 months

    Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation.

  108. Machine flow during controlled oxygenated rewarming

    Time frame: 1 hour

    Machine flow (millilitre/hour)

  109. Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion

    Time frame: 1 hour

    Machine flow (millilitre/hour)

  110. Machine pressure during controlled oxygenated rewarming

    Time frame: 1 hour

    Machine pressure ((millimetre Hg))

  111. Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion

    Time frame: 1 hour

    Machine pressure ((millimetre Hg))

  112. Machine Fraction of oxygen during controlled oxygenated rewarming

    Time frame: 1 hour

    Machine fraction of oxygen (%)

  113. Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion

    Time frame: 1 hour

    Machine fraction of oxygen (%)

  114. Machine Resistance during controlled oxygenated rewarming

    Time frame: 1 hour

    Machine Resistance (millilitre/minute/millimetre Hg)

  115. Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion

    Time frame: 1 hour

    Machine Resistance (millilitre/minute/millimetre Hg)

  116. Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion

    Time frame: 2 hours

    Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion flow (millilitre/hour)

  117. Machine flow during normothermic machine perfusion

    Time frame: 4 hours

    Machine flow during normothermic machine perfusion (millilitre/hour)

  118. Machine flow during normothermic machine perfusion

    Time frame: 2.5 hours

    Machine flow during normothermic machine perfusion (millilitre/hour)

  119. Machine pressure during normothermic machine perfusion

    Time frame: 4 hours

    Machine pressure (millimetre Hg)

  120. Machine pressure during normothermic machine perfusion

    Time frame: 2.5 hours

    Machine pressure (millimetre Hg)

  121. Machine Fraction of oxygen during normothermic machine perfusion

    Time frame: 4 hours

    Machine fraction of oxygen (%)

  122. Machine Fraction of oxygen during normothermic machine perfusion

    Time frame: 2.5 hours

    Machine fraction of oxygen (%)

  123. Machine Resistance during normothermic machine perfusion

    Time frame: 4 hours

    Machine Resistance (millilitre/minute/millimetre Hg)

  124. Machine Resistance during normothermic machine perfusion

    Time frame: 2.5 hours

    Machine Resistance (millilitre/minute/millimetre Hg)

  125. Total preservation time

    Time frame: 48 hours

    Total preservation time (machine perfusion time)

  126. Alanine amino transferase in perfusate during machine perfusion

    Time frame: 24 hours

    Alanine amino transferase in perfusate during machine perfusion (U/Litre)

  127. Aspartate amino transferase in perfusate during machine perfusion

    Time frame: 24 hours

    Aspartate amino transferase in perfusate during machine perfusion (U/Litre)

  128. Alkaline phosphatase in perfusate during machine perfusion

    Time frame: 24 hours

    Aspartate amino transferase in perfusate during machine perfusion (U/Litre)

  129. Gamma-glutamyl transferase in perfusate during machine perfusion

    Time frame: 24 hours

    Gamma-glutamyl transferase in perfusate during machine perfusion (U/Litre)

  130. Urea in perfusate during machine perfusion

    Time frame: 24 hours

    Urea in perfusate during machine perfusion (millimol/Litre)

  131. Bilirubin in perfusate during machine perfusion

    Time frame: 24 hours

    Bilirubin in perfusate during machine perfusion (micromol/Litre)

  132. Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion

    Time frame: 24 hours

    Different cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion

  133. Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion

    Time frame: 24 hours

    Different cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion

  134. Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion

    Time frame: 24 hours

    Different cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion

  135. Histopathology - liver tissue. Mitochondrial function

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for mitochondrial function.

  136. Histopathology - bile duct. Mitochondrial function

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for mitochondrial function.

  137. Histopathology - liver tissue. Perfusion/reperfusion injury

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury

  138. Histopathology - bile duct. Perfusion/reperfusion injury

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for perfusion/reperfusion injury

  139. Histopathology - liver tissue. Cell death

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for cell death

  140. Histopathology - bile duct. Cell death

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for cell death

  141. Histopathology - liver tissue. Inflammation

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for inflammation

  142. Histopathology - bile duct. Inflammation

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for inflammation

  143. Histopathology - liver tissue. Metabolomics

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for metabolomics

  144. Histopathology - bileduct. Metabolomics

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for metabolomics

  145. Histopathology - liver tissue. Lipidomics

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for lipidomics

  146. Histopathology - bile duct. Lipidomics

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for lipidomics

  147. Histopathology - liver tissue. RNA sequencing

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for RNA sequencing

  148. Histopathology - bile duct. RNA sequencing

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for RNA sequencing

  149. Histopathology - liver tissue. Endothelium properties

    Time frame: During machine perfusion - 24 hours

    Histological analysis of parenchymal biopsies which are assessed for endothelium properties

  150. Histopathology - bile duct. Endothelium properties

    Time frame: During machine perfusion - 24 hours

    Histological analysis of bile duct biopsies which are assessed for endothelium properties

  151. International normalized ratio on postoperative day 7

    Time frame: 7 postoperative day

    Blood sample from recipient: International normalized ratio on postoperative day 7

  152. Alanine amino transferase postoperative day 0

    Time frame: Postoperative day 0

    Alanine amino transferase postoperative day 0 in the donated recipients (U/Litre)

  153. Aspartate amino transferase postoperative day 0

    Time frame: Postoperative day 0

    Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre)

  154. Alkaline phosphatase postoperative day 0

    Time frame: Postoperative day 0

    Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre)

  155. Gamma-glutamyl transferase postoperative day 0

    Time frame: Postoperative day 0

    Gamma-glutamyl transferase postoperative day 0 in the donated recipients (U/Litre)

  156. Urea postoperative day 0

    Time frame: Postoperative day 0

    Urea postoperative day 0 in the donated recipients (millimol/Litre)

  157. Bilirubin postoperative day 0

    Time frame: Postoperative day 0

    Bilirubin postoperative day 0 in the donated recipients (micromol/Litre)

  158. Bilirubin postoperative day 1

    Time frame: Postoperative day 1

    Bilirubin postoperative day 1 in the donated recipients (micromol/Litre)

  159. Bilirubin postoperative day 2

    Time frame: Postoperative day 2

    Bilirubin postoperative day 2 in the donated recipients (micromol/Litre)

  160. Bilirubin postoperative day 3

    Time frame: Postoperative day 3

    Bilirubin postoperative day 3 in the donated recipients (micromol/Litre)

  161. Bilirubin postoperative day 4

    Time frame: Postoperative day 4

    Bilirubin postoperative day 4 in the donated recipients (micromol/Litre)

  162. Bilirubin postoperative day 5

    Time frame: Postoperative day 5

    Bilirubin postoperative day 5 in the donated recipients (micromol/Litre)

  163. Bilirubin postoperative day 6

    Time frame: Postoperative day 6

    Bilirubin postoperative day 6 in the donated recipients (micromol/Litre)

  164. Bilirubin postoperative day 7

    Time frame: Postoperative day 7

    Bilirubin postoperative day 7 in the donated recipients (micromol/Litre)

  165. Urea postoperative day 1

    Time frame: Postoperative day 1

    Urea postoperative day 1 in the donated recipients (millimol/Litre)

  166. Urea postoperative day 2

    Time frame: Postoperative day 2

    Urea postoperative day 2 in the donated recipients (millimol/Litre)

  167. Urea postoperative day 3

    Time frame: Postoperative day 3

    Urea postoperative day 3 in the donated recipients (millimol/Litre)

  168. Urea postoperative day 4

    Time frame: Postoperative day 4

    Urea postoperative day 4 in the donated recipients (millimol/Litre)

  169. Urea postoperative day 5

    Time frame: Postoperative day 5

    Urea postoperative day 5 in the donated recipients (millimol/Litre)

  170. Urea postoperative day 6

    Time frame: Postoperative day 6

    Urea postoperative day 6 in the donated recipients (millimol/Litre)

  171. Urea postoperative day 7

    Time frame: Postoperative day 7

    Urea postoperative day 7 in the donated recipients (millimol/Litre)

  172. Aspartate amino transferase postoperative day 1

    Time frame: Postoperative day 1

    Aspartate amino transferase postoperative day 1 in the donated recipients (U/Litre)

  173. Alkaline phosphatase postoperative day 1

    Time frame: Postoperative day 1

    Alkaline phosphatase postoperative day 1 in the donated recipients (U/Litre)

  174. Gamma-glutamyl transferase postoperative day 1

    Time frame: Postoperative day 1

    Gamma-glutamyl transferase postoperative day 1 in the donated recipients (U/Litre)

  175. Alanine amino transferase postoperative day 2

    Time frame: Postoperative day 2

    Alanine amino transferase postoperative day 2 in the donated recipients (U/Litre)

  176. Aspartate amino transferase postoperative day 2

    Time frame: Postoperative day 2

    Aspartate amino transferase postoperative day 2 in the donated recipients (U/Litre)

  177. Alkaline phosphatase postoperative day 2

    Time frame: Postoperative day 2

    Alkaline phosphatase postoperative day 2 in the donated recipients (U/Litre)

  178. Gamma-glutamyl transferase postoperative day 2

    Time frame: Postoperative day 2

    Gamma-glutamyl transferase postoperative day 2 in the donated recipients (U/Litre)

  179. Alanine amino transferase postoperative day 3

    Time frame: Postoperative day 3

    Alanine amino transferase postoperative day 3 in the donated recipients (U/Litre)

  180. Aspartate amino transferase postoperative day 3

    Time frame: Postoperative day 3

    Aspartate amino transferase postoperative day 3 in the donated recipients (U/Litre)

  181. Alkaline phosphatase postoperative day 3

    Time frame: Postoperative day 3

    Alkaline phosphatase postoperative day 3 in the donated recipients (U/Litre)

  182. Gamma-glutamyl transferase postoperative day 3

    Time frame: Postoperative day 3

    Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre)

  183. Alanine amino transferase postoperative day 4

    Time frame: Postoperative day 4

    Alanine amino transferase postoperative day 4 in the donated recipients (U/Litre)

  184. Aspartate amino transferase postoperative day 4

    Time frame: Postoperative day 4

    Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre)

  185. Alkaline phosphatase postoperative day 4

    Time frame: Postoperative day 4

    Alkaline phosphatase postoperative day 4 in the donated recipients (U/Litre)

  186. Gamma-glutamyl transferase postoperative day 4

    Time frame: Postoperative day 4

    Gamma-glutamyl transferase postoperative day 4 in the donated recipients (U/Litre)

  187. Alanine amino transferase postoperative day 5

    Time frame: Postoperative day 5

    Alanine amino transferase postoperative day 5 in the donated recipients (U/Litre)

  188. Aspartate amino transferase postoperative day 5

    Time frame: Postoperative day 5

    Aspartate amino transferase postoperative day 5 in the donated recipients (U/Litre)

  189. Alkaline phosphatase postoperative day 5

    Time frame: Postoperative day 5

    Alkaline phosphatase postoperative day 5 in the donated recipients (U/Litre)

  190. Gamma-glutamyl transferase postoperative day 5

    Time frame: Postoperative day 5

    Gamma-glutamyl transferase postoperative day 5 in the donated recipients (U/Litre)

  191. Alanine amino transferase postoperative day 6

    Time frame: Postoperative day 6

    Alanine amino transferase postoperative day 6 in the donated recipients (U/Litre)

  192. Aspartate amino transferase postoperative day 6

    Time frame: Postoperative day 6

    Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)

  193. Alkaline phosphatase postoperative day 6

    Time frame: Postoperative day 6

    Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)

  194. Gamma-glutamyl transferase postoperative day 6

    Time frame: Postoperative day 6

    Gamma-glutamyl transferase postoperative day 6 in the donated recipients (U/Litre)

  195. Alanine amino transferase postoperative day 7

    Time frame: Postoperative day 7

    Alanine amino transferase postoperative day 7 in the donated recipients (U/Litre)

  196. Aspartate amino transferase postoperative day 7

    Time frame: Postoperative day 7

    Aspartate amino transferase postoperative day 7 in the donated recipients (U/Litre)

  197. Alkaline phosphatase postoperative day 7

    Time frame: Postoperative day 7

    Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre)

  198. Gamma-glutamyl transferase postoperative day 7

    Time frame: Postoperative day 7

    Gamma-glutamyl transferase postoperative day 7 in the donated recipients (U/Litre)

  199. Alanine amino transferase postoperative month 1

    Time frame: 1 month after surgery

    Alanine amino transferase postoperative month 1 in the donated recipients (U/Litre)

  200. Aspartate amino transferase postoperative month 1

    Time frame: 1 month after surgery

    Aspartate amino transferase postoperative month 1 in the donated recipients (U/Litre)

  201. Alkaline phosphatase postoperative month 1

    Time frame: 1 month after surgery

    Alkaline phosphatase postoperative month 1 in the donated recipients (U/Litre)

  202. Gamma-glutamyl transferase postoperative month 1

    Time frame: 1 month after surgery

    Gamma-glutamyl transferase postoperative month 1 in the donated recipients (U/Litre)

  203. Urea postoperative month 1

    Time frame: 1 month after surgery

    Urea postoperative month 1 in the donated recipients (millimol/Litre)

  204. Bilirubin postoperative month 1

    Time frame: 1 month after surgery

    Bilirubin postoperative month 1 in the donated recipients (micromol/Litre)

  205. Bilirubin postoperative month 2

    Time frame: 2 month after surgery

    Bilirubin postoperative month 2 in the donated recipients (micromol/Litre)

  206. Bilirubin postoperative month 3

    Time frame: 3 month after surgery

    Bilirubin postoperative month 3 in the donated recipients (micromol/Litre)

  207. Bilirubin postoperative month 4

    Time frame: 4 month after surgery

    Bilirubin postoperative month 4 in the donated recipients (micromol/Litre)

  208. Bilirubin postoperative month 5

    Time frame: 5 month after surgery

    Bilirubin postoperative month 5 in the donated recipients (micromol/Litre)

  209. Bilirubin postoperative month 6

    Time frame: 6 month after surgery

    Bilirubin postoperative month 6 in the donated recipients (micromol/Litre)

  210. Bilirubin postoperative month 7

    Time frame: 7 month after surgery

    Bilirubin postoperative month 7 in the donated recipients (micromol/Litre)

  211. Bilirubin postoperative month 8

    Time frame: 8 month after surgery

    Bilirubin postoperative month 8 in the donated recipients (micromol/Litre)

  212. Bilirubin postoperative month 9

    Time frame: 9 month after surgery

    Bilirubin postoperative month 9 in the donated recipients (micromol/Litre)

  213. Bilirubin postoperative month 10

    Time frame: 10 month after surgery

    Bilirubin postoperative month 10 in the donated recipients (micromol/Litre)

  214. Bilirubin postoperative month 11

    Time frame: 11 month after surgery

    Bilirubin postoperative month 11 in the donated recipients (micromol/Litre)

  215. Bilirubin postoperative month 12

    Time frame: 12 month after surgery

    Bilirubin postoperative month 12 in the donated recipients (micromol/Litre)

  216. Urea postoperative month 2

    Time frame: 2 month after surgery

    Urea postoperative month 2 in the donated recipients (millimol/Litre)

  217. Urea postoperative month 3

    Time frame: 3 month after surgery

    Urea postoperative month 3 in the donated recipients (millimol/Litre)

  218. Urea postoperative month 4

    Time frame: 4 month after surgery

    Urea postoperative month 4 in the donated recipients (millimol/Litre)

  219. Urea postoperative month 5

    Time frame: 5 month after surgery

    Urea postoperative month 5 in the donated recipients (millimol/Litre)

  220. Urea postoperative month 6

    Time frame: 6 month after surgery

    Urea postoperative month 6 in the donated recipients (millimol/Litre)

  221. Urea postoperative month 7

    Time frame: 7 month after surgery

    Urea postoperative month 7 in the donated recipients (millimol/Litre)

  222. Urea postoperative month 8

    Time frame: 8 month after surgery

    Urea postoperative month 8 in the donated recipients (millimol/Litre)

  223. Urea postoperative month 9

    Time frame: 9 month after surgery

    Urea postoperative month 9 in the donated recipients (millimol/Litre)

  224. Urea postoperative month 10

    Time frame: 10 month after surgery

    Urea postoperative month 10 in the donated recipients (millimol/Litre)

  225. Urea postoperative month 11

    Time frame: 11 month after surgery

    Urea postoperative month 11 in the donated recipients (millimol/Litre)

  226. Urea postoperative month 12

    Time frame: 12 month after surgery

    Urea postoperative month 12 in the donated recipients (millimol/Litre)

  227. Alanine amino transferase postoperative month 2

    Time frame: 2 month after surgery

    Alanine amino transferase postoperative month 2 in the donated recipients (U/Litre)

  228. Aspartate amino transferase postoperative month 2

    Time frame: 2 month after surgery

    Aspartate amino transferase postoperative month 2 in the donated recipients (U/Litre)

  229. Alkaline phosphatase postoperative month 2

    Time frame: 2 month after surgery

    Alkaline phosphatase postoperative month 2 in the donated recipients (U/Litre)

  230. Gamma-glutamyl transferase postoperative month 2

    Time frame: 2 month after surgery

    Gamma-glutamyl transferase postoperative month 2 in the donated recipients (U/Litre)

  231. Alanine amino transferase postoperative month 3

    Time frame: 3 month after surgery

    Alanine amino transferase postoperative month 3 in the donated recipients (U/Litre)

  232. Aspartate amino transferase postoperative month 3

    Time frame: 3 month after surgery

    Aspartate amino transferase postoperative month 3 in the donated recipients (U/Litre)

  233. Alkaline phosphatase postoperative month 3

    Time frame: 3 month after surgery

    Alkaline phosphatase postoperative month 3 in the donated recipients (U/Litre)

  234. Gamma-glutamyl transferase postoperative month 3

    Time frame: 3 month after surgery

    Gamma-glutamyl transferase postoperative month 3 in the donated recipients (U/Litre)

  235. Alanine amino transferase postoperative month 4

    Time frame: 4 month after surgery

    Alanine amino transferase postoperative month 4 in the donated recipients (U/Litre)

  236. Aspartate amino transferase postoperative month 4

    Time frame: 4 month after surgery

    Aspartate amino transferase postoperative month 4 in the donated recipients (U/Litre)

  237. Alkaline phosphatase postoperative month 4

    Time frame: 4 month after surgery

    Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre)

  238. Gamma-glutamyl transferase postoperative month 4

    Time frame: 4 month after surgery

    Gamma-glutamyl transferase postoperative month 4 in the donated recipients (U/Litre)

  239. Alanine amino transferase postoperative month 5

    Time frame: 5 month after surgery

    Alanine amino transferase postoperative month 5 in the donated recipients (U/Litre)

  240. Aspartate amino transferase postoperative month 5

    Time frame: 5 month after surgery

    Aspartate amino transferase postoperative month 5 in the donated recipients (U/Litre)

  241. Alkaline phosphatase postoperative month 5

    Time frame: 5 month after surgery

    Alkaline phosphatase postoperative month 5 in the donated recipients (U/Litre)

  242. Gamma-glutamyl transferase postoperative month 5

    Time frame: 5 month after surgery

    Gamma-glutamyl transferase postoperative month 5 in the donated recipients (U/Litre)

  243. Alanine amino transferase postoperative month 6

    Time frame: 6 month after surgery

    Alanine amino transferase postoperative month 6 in the donated recipients (U/Litre)

  244. Aspartate amino transferase postoperative month 6

    Time frame: 6 month after surgery

    Aspartate amino transferase postoperative month 6 in the donated recipients (U/Litre)

  245. Alkaline phosphatase postoperative month 6

    Time frame: 6 month after surgery

    Alkaline phosphatase postoperative month 6 in the donated recipients (U/Litre)

  246. Gamma-glutamyl transferase postoperative month 6

    Time frame: 6 month after surgery

    Gamma-glutamyl transferase postoperative month 6 in the donated recipients (U/Litre)

  247. Alanine amino transferase postoperative month 7

    Time frame: 7 month after surgery

    Alanine amino transferase postoperative month 7 in the donated recipients (U/Litre)

  248. Aspartate amino transferase postoperative month 7

    Time frame: 7 month after surgery

    Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre)

  249. Alkaline phosphatase postoperative month 7

    Time frame: 7 month after surgery

    Alkaline phosphatase postoperative month 7 in the donated recipients (U/Litre)

  250. Gamma-glutamyl transferase postoperative month 7

    Time frame: 7 month after surgery

    Gamma-glutamyl transferase postoperative month 7 in the donated recipients (U/Litre)

  251. Alanine amino transferase postoperative month 8

    Time frame: 8 month after surgery

    Alanine amino transferase postoperative month 8 in the donated recipients (U/Litre)

  252. Aspartate amino transferase postoperative month 8

    Time frame: 8 month after surgery

    Aspartate amino transferase postoperative month 8 in the donated recipients (U/Litre)

  253. Alkaline phosphatase postoperative month 8

    Time frame: 8 month after surgery

    Alkaline phosphatase postoperative month 8 in the donated recipients (U/Litre)

  254. Gamma-glutamyl transferase postoperative month 8

    Time frame: 8 month after surgery

    Gamma-glutamyl transferase postoperative month 8 in the donated recipients (U/Litre)

  255. Alanine amino transferase postoperative month 9

    Time frame: 9 month after surgery

    Alanine amino transferase postoperative month 9 in the donated recipients (U/Litre)

  256. Aspartate amino transferase postoperative month 9

    Time frame: 9 month after surgery

    Aspartate amino transferase postoperative month 9 in the donated recipients (U/Litre)

  257. Alkaline phosphatase postoperative month 9

    Time frame: 9 month after surgery

    Alkaline phosphatase postoperative month 9 in the donated recipients (U/Litre)

  258. Gamma-glutamyl transferase postoperative month 9

    Time frame: 9 month after surgery

    Gamma-glutamyl transferase postoperative month 9 in the donated recipients (U/Litre)

  259. Alanine amino transferase postoperative month 10

    Time frame: 10 month after surgery

    Alanine amino transferase postoperative month 10 in the donated recipients (U/Litre)

  260. Aspartate amino transferase postoperative month 10

    Time frame: 10 month after surgery

    Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre)

  261. Alkaline phosphatase postoperative month 10

    Time frame: 10 month after surgery

    Alkaline phosphatase postoperative month 10 in the donated recipients (U/Litre)

  262. Gamma-glutamyl transferase postoperative month 10

    Time frame: 10 month after surgery

    Gamma-glutamyl transferase postoperative month 10 in the donated recipients (U/Litre)

  263. Alanine amino transferase postoperative month 11

    Time frame: 11 month after surgery

    Alanine amino transferase postoperative month 11 in the donated recipients (U/Litre)

  264. Aspartate amino transferase postoperative month 11

    Time frame: 11 month after surgery

    Aspartate amino transferase postoperative month 11 in the donated recipients (U/Litre)

  265. Alkaline phosphatase postoperative month 11

    Time frame: 11 month after surgery

    Alkaline phosphatase postoperative month 11 in the donated recipients (U/Litre)

  266. Gamma-glutamyl transferase postoperative month 11

    Time frame: 11 month after surgery

    Gamma-glutamyl transferase postoperative month 11 in the donated recipients (U/Litre)

  267. Alanine amino transferase postoperative month 12

    Time frame: 12 month after surgery

    Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre)

  268. Aspartate amino transferase postoperative month 12

    Time frame: 12 month after surgery

    Aspartate amino transferase postoperative month 12 in the donated recipients (U/Litre)

  269. Alkaline phosphatase postoperative month 12

    Time frame: 12 month after surgery

    Alkaline phosphatase postoperative month 12 in the donated recipients (U/Litre)

  270. Gamma-glutamyl transferase postoperative month 12

    Time frame: 12 month after surgery

    Gamma-glutamyl transferase postoperative month 12 in the donated recipients (U/Litre)

  271. Postoperative microdialysis levels of lactate

    Time frame: 14 days

    Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days

  272. Postoperative microdialysis levels of pyruvate

    Time frame: 14 days

    Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days

  273. Postoperative microdialysis levels of glycerol

    Time frame: 14 days

    Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days

  274. Postoperative microdialysis levels of glucose

    Time frame: 14 days

    Postoperative microdialysis levels of glucose in transplanted livers the first 14 postoperative days

  275. Systolic blood pressure

    Time frame: From 5 min before reperfusion, up to 20 minutes after reperfusion

    Systolic blood pressure (millimeter Hg)

  276. Diastolic blood pressure

    Time frame: From 5 min before reperfusion, up to 20 minutes after reperfusion

    Diastolic blood pressure (millimeter Hg)

  277. Heart rate

    Time frame: From 5 min before reperfusion, up to 20 minutes after reperfusion

    Heart rate (Beats/minute)

  278. Vasopressor dosage

    Time frame: From 5 min before reperfusion, up to 20 minutes after reperfusion

    Vasopressor dosage (microgram/kilogram/minutes)

  279. Patient survival

    Time frame: Through study completion, an average of 12 months

    Patient survival (days)

  280. Graft survival

    Time frame: Through study completion, an average of 12 months

    Graft (censored and uncensored for patient death) survival (days)

  281. Number of deaths

    Time frame: 7 days after transplantation

    Number of deaths first 7 days after transplantation

  282. Number of retransplantation

    Time frame: 7 days after transplantation

    Number of retransplantation first 7 days after transplantation

  283. Incidens of new onset diabetes after transplantation

    Time frame: Through study completion, an average of 12 months

    New onset diabetes after transplantation after transplantation. New onset diabetes after transplantation is defined according to the World Health Organization criteria (Report 2003 S5-20).

  284. Estimated glomerular filtration rate - Renal function

    Time frame: Through study completion, an average of 12 months

    Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease equation.

  285. The incidence of symptomatic Non-anastomotic Biliary Strictures

    Time frame: 6 months

    The incidence of symptomatic non-anastomotic biliary strictures

  286. The incidence of asymptomatic Non-anastomotic Biliary Strictures

    Time frame: 6 months

    The incidence of asymptomatic non-anastomotic biliary strictures

  287. The incidence of asymptomatic Non-anastomotic Biliary Strictures

    Time frame: 12 months

    The incidence of asymptomatic non-anastomotic biliary strictures

  288. The incidence of symptomatic Non-anastomotic Biliary Strictures

    Time frame: 12 months

    The incidence of symptomatic non-anastomotic biliary strictures

  289. The severity of Non-anastomotic Biliary Strictures

    Time frame: Through study completion, an average of 12 months

    The severity of Non-anastomotic Biliary Strictures based on a scoring system described by Buis et. al (mild, moderate, or severe)

  290. The location of Non-anastomotic Biliary Strictures

    Time frame: Through study completion, an average of 12 months

    The location of Non-anastomotic Biliary Strictures is assessed by images of the magnetic resonance cholangiopancreatography

  291. The incidence of infections

    Time frame: Through study completion, an average of 12 months

    The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment

  292. Lactate level in microdialysate from liver tissue - 4 hours

    Time frame: 4 hours

    Microdialysis lactate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.

  293. Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

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

  294. Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

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

  295. Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours

    Time frame: 4 hours

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

  296. Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 2 hours

    Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  297. Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours

    Time frame: 2 hours

    Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  298. Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  299. Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  300. Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  301. Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour

    Time frame: 1 hour

    Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.

  302. Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours

    Time frame: 2 hour

    Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

  303. Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours

    Time frame: 2 hour

    Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

Other outcomes

  1. Donor associated variables - age

    Time frame: 1 hour

    Age of the donor (years)

  2. Donor associated variables - liver steatosis

    Time frame: 1 hour

    Assessment of liver steatosis (%)

  3. Donor associated variables - gender

    Time frame: 1 hour

    Gender of donor

  4. Donor associated variables - Body mass index

    Time frame: 1 hour

    Body mass index of donor (kilogram/meter2)

  5. Donor associated variables - weight of the liver

    Time frame: 1 hour

    Weight of the liver (gram)

  6. Ischemia time - warm

    Time frame: 12 hour

    Estimation of warm ischemia time (minutes)

  7. Ischemia time - cold

    Time frame: 12 hour

    Estimation of cold ischemia time (minutes)

  8. Donor associated variables - Donor risk index

    Time frame: 1 hour

    Donor risk index score - Increasing donor risk index is associated with higher discard rates among deceased donor livers procured for transplant. Low value of 1= best prognosis. High value of 40 = worst prognosis

Study contacts

Contact information is provided by the study sponsor or research team.

Søren E Pischke, MD, PhD

CONTACT

[email protected]

45486579 ext. +47

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study

Acronym: EVOLVE

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 18, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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