Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion With Standard Static Cold Storage of Liver Grafts Donated After Circulatory Death in Preventing Biliary Complications
Brief Summary: Rationale: Recent publications report good results of controlled donation after circulatory death (DCD) Maastricht category III liver transplantation when strict donor-recipient matching is applied and ischemia times are kept to a minimum. However a major concern remains the high rate of biliary complications after transplantation of DCD livers. Non-anastomotic biliary strictures (NAS) occur in 29% of patients receiving a DCD graft whereas the incidence of NAS in recipients of donation after brain death (DBD) liver grafts is 11%. NAS are associated with higher morbidity and increased cost of liver transplantation. Injury to the biliary epithelium and the peribiliary vascular plexus occurring during donor warm ischemia and static cold storage (SCS) has been identified as a major risk factor for development of NAS. Machine perfusion has been proposed as an alternative strategy for organ preservation, offering the opportunity to improve the quality of the organ by providing oxygen to the graft. Experimental studies have shown that end-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) helps liver grafts to recover from ischemia by restoring mitochondrial function. Moreover, DHOPE has been shown to provide better preservation of peribiliary vascular plexus of the bile ducts, which could be an important step forward in reducing the incidence of NAS after transplantation.

Objective: To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS within six months after controlled DCD (Maastricht category III) liver transplantation.

Study design: An international, multicenter, prospective, randomized, controlled, interventional, clinical trial with a two parallel arm approach (treatment/control).

Study population: Adult patients (≥18 yrs old) undergoing a liver transplantation with a liver graft procured from a controlled DCD donor (Maastricht category III) with a body weight ≥40 kg.

Intervention: In the intervention group liver grafts will be subjected to two hours of hypothermic, oxygenated perfusion at the end of SCS and before implantation. In the control group donor liver grafts will be preserved in accordance to standard practice by SCS only.

Main study parameters/endpoints: The incidence and severity of symptomatic NAS as diagnosed by an Adjudication committee (who are blinded for the group assignment) by means of magnetic resonance cholangiopancreatography (MRCP).


Options:
A: 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
B: 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
C: 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
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: D