Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Multicenter Study on the Effects of Hypothermic Oxygenated Perfusion (HOPE) on Human Liver Grafts Before Transplantation
Brief Summary: The purpose of this study is, in a randomized trial, to test a newly developed machine perfusion technique of human liver allografts before transplantation.

Ischemia-reperfusion injury is universal in organ transplantation and leads to varying degrees of graft dysfunction. Despite this fact, the preservation method in organ transplantation has been left unchanged for many years and remains simple static cold storage. Given the scarce donor supply, an increasing number of so called marginal or extended criteria donor organs have been used for liver transplantation, grafts which were previously rarely considered. In addition, allocation policy has changed in many countries, and livers are currently often distributed by the severity of the recipient's disease. As a result, transplant candidates present sicker, with higher MELD (Model for end stage liver disease) scores, at the time of transplant,and the risk of graft dysfunction or even failure due to reperfusion injury is high after the use of marginal livers in sick recipients.

Machine liver perfusion techniques have been significantly improved during the past decade to decrease reperfusion injury, and a number of promising results show beneficial effects in various animal transplant models by either normothermic or hypothermic oxygenated continuous liver perfusion. These techniques generally require machine liver perfusion immediately after organ procurement. However, continuous perfusion has several drawbacks, including major logistic efforts and risk of organ damage during perfusion and transport.

Our group, therefore, focused on the practicability of machine liver perfusion. We developed an endischemic hypothermic oxygenated perfusion (HOPE) concept through the portal vein only. This technique can be easily applied in the operation room shortly before transplantation of the recipient, thus after organ transport and back table preparation.

Recently, the beneficial effect of a similar approach has been confirmed in human liver grafts by a phase I non randomized trial. These results prove feasibility and safety of an endischemic hypothermic machine perfusion approach and warrant further randomized studies.


Options:
A: Inclusion Criteria:

* Patients older than 18 years
* Candidates for a first orthotopic liver transplantation, without transplantation of another associated organ (kidney, pancreas, heart, lung, intestine)
* With cirrhosis whatever its etiology and gravity
* With or without hepatocarcinoma
* Having given free, informed and written consent
* LT made from a whole graft, harvested from a brain-dead donor with ECD criteria, defined as the presence of at least one of the following criteria:

  * Age\> 65 years
  * BMI\> 30 kg / m2
  * Duration of hospitalization in intensive care unit\> 7 days
  * Natremia\> 155 mmol / l
  * AST\> 150 IU / ml
  * ALT\> 170 IU / ml
  * Occurrence of cardiac arrest before harvesting
  * Macrovacuolar steatosis\> 30% on liver histology

Exclusion Criteria:

* History of organ transplantation
* Transplantation in emergency
* Transplantation from a living donor, a reduced graft or a graft from a deceased donor by cardiac arrest (DCD)
* Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
B: Inclusion Criteria:

* Adult (≥18 years) patients with acute liver failure or liver cirrhosis (CHILD A, B or C) and/ or malignant liver tumors requiring liver transplantation
* Whole liver graft
* Signed informed consent

Exclusion Criteria:

* Split graft
* Living donor liver transplantation
* Grafts donated after cardiac arrest (DCD grafts)
* Domino transplantation
* Combined liver transplant
* Cold storage \> 15h
* acute and unexpected medical contraindication
C: Inclusion Criteria for all participants:

* Received single lung, heart, kidney, or liver transplant
* Specimens of donor tissues have been collected
* Parent or guardian willing to provide informed consent, if applicable

Inclusion Criteria for Kidney or Liver Transplant Participants:

* 70 years old or younger

Inclusion Criteria for Heart or Lung Transplant Participants:

* Between 16 and 70 years old

Exclusion Criteria for All Participants:

* Previous solid organ transplant
* Need for combined organ transplant
* HIV or hepatitis C virus infection
* Recipient of an organ from a hepatitis C virus-infected donor
* Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation
* Living donor transplant recipient of either a kidney, liver, or lung
D: Inclusion Criteria:

* Adult patients (≥ 18 years old)
* Signed informed consent
* Willing and able to attend follow-up examinations
* Donor liver graft from a controlled donation after circulatory death (Maastricht category III)
* Donors with a body weight ≥40 kg

Exclusion Criteria:

* Simultaneous participation in another clinical trial that might possibly influence this trial
* Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
* Listed for liver transplantation due to fulminant liver failure or retransplantation because of primary non-function
* Recipient positive test for HIV
* Donor positive for HIV antigen, hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody
* Simultaneous transplantation of another organ
* Patients with contra-indications for MRCP (i.e. pacemaker)

Answer: B