Please select the eligibility criteria that correspond to the clinical trial below.
Title: Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol of a Randomised Single Center Clinical Trial of Hypothermic Oxygenated Perfusion Versus Static Cold Storage
Brief Summary: With the present study the investigators will evaluate the benefit of end-ischemic HOPE on ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a recently developed machine perfusion (MP) device, from the beginning of back-table procedures till implantation, without increasing CIT. The aim of the study will be demonstrating the ability of HOPE to improve graft function and post-operative outcomes of ECD kidney and liver recipients.


Options:
A: Inclusion Criteria:

* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria:

* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \>3 mg/dl for \>2 weeks and/or requiring hemodialysis
* Multi-organ transplant
* Ventilator dependent
* Dependent on \> 1 IV inotrope to maintain hemodynamics
B: 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
C: Inclusion Criteria:

-Patients with signed informed consent, suffering from end stage-liver disease and/or malignant liver tumors listed for liver transplantation and receiving ECD organs.

ECD Criteria are defined as:

* Donors 65 years of age and older
* Intensive therapy of the donor was required before donation for at least 7 days, --Obesity of the donor with a Body Mass Index \> 30
* Fatty liver (with histology) \> 40 %
* Serum-Sodium \> 165 mmol/l
* Serum AST or ALT \> 3 x normal, Serum-Bilirubin \> 2 mg/dl)

Exclusion Criteria:

* Recipients of split of living donor liver transplants
* Previous liver transplantation
* Combined transplantations (liver-kidney, liver-lung, etc.)
* Participation in other liver related trials
* The subject received an investigational drug within 30 days prior to inclusion
* The subject is unwilling or unable to follow the procedures outlined in the protocol
* The subject is mentally or legally incapacitated
* Patient is not able to understand the procedures due to language barriers
* Family members of the investigators or employees of the participating department
D: Inclusion Criteria:

* For kidneys: donor age ≥ 60 years or 50-59 years with two or more of the sequent risk factors: death due to cerebrovascular accident, history of hypertension, donor serum creatinine \> 1.5 mg/dL, cold ischemia time (CIT) \> 20 h;
* For livers: donors with hemodynamic deterioration, donor age \> 65 years, donor body mass index \> 30 kg/m2, serum bilirubin \> 3 mg/dl, AST or ALT above three times the upper reference threshold, sodium \> 165 mmol/l, intensive care unit (ICU) stay \> 7 days, steatosis \> 40%, CIT \> 12 h.

Exclusion Criteria:

* Donor age ≤18 years;
* Donors after circulatory death (DCD) will be excluded, because Italian law requires 20 minutes of "no touch period" before death declaration, causing prolonged warm ischemia and subsequent mandatory perfusion of the organ.
* Split-liver recipients, liver transplantation (LT) for acute liver failure, pre-emptive renal transplant, dual kidney transplantation, and patients with intra-operative surgical complications before the organ implantation.

Answer: D