Please select the arm or intervention descriptions that belong 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: Arm Label: Kidney transplants; Type: N/A; Interventions: N/A | Arm Label: Liver transplants; Type: N/A; Interventions: N/A | Arm Label: Heart transplants; Type: N/A; Interventions: N/A | Arm Label: Lung transplants; Type: N/A; Interventions: N/A
B: Arm Label: Hypothermic oxygenated perfusion (HOPE); Type: EXPERIMENTAL; Interventions: Device: Hypothermic oxygenated perfusion (HOPE) | Arm Label: Conventional cold storage (CCS); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Conventional cold storage (CCS) | Intervention Type: DEVICE; Name: Hypothermic oxygenated perfusion (HOPE); Assigned to Arm(s): Hypothermic oxygenated perfusion (HOPE) | Intervention Type: PROCEDURE; Name: Conventional cold storage (CCS); Assigned to Arm(s): Conventional cold storage (CCS)
C: Arm Label: OCS Liver System; Type: EXPERIMENTAL; Interventions: Device: OCS™ Liver System | Arm Label: Control; Type: OTHER; Interventions: Other: Control | Intervention Type: DEVICE; Name: OCS™ Liver System; Assigned to Arm(s): OCS Liver System | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control
D: Arm Label: Dual hypothermic oxygenated perfusion; Type: EXPERIMENTAL; Interventions: Procedure: Dual hypothermic oxygenated perfusion, Device: Liver Assist®, Procedure: Perfusion fluid, Drug: Glutathione | Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Dual hypothermic oxygenated perfusion; Assigned to Arm(s): Dual hypothermic oxygenated perfusion | Intervention Type: DEVICE; Name: Liver Assist®; Assigned to Arm(s): Dual hypothermic oxygenated perfusion | Intervention Type: PROCEDURE; Name: Perfusion fluid; Assigned to Arm(s): Dual hypothermic oxygenated perfusion | Intervention Type: DRUG; Name: Glutathione; Assigned to Arm(s): Dual hypothermic oxygenated perfusion

Answer: D