Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hypothermic Oxygenated Machine Perfusion (HOPE) for Liver Transplantation of Human Liver Allografts From Extended Criteria Donors (ECD) in Donation After Brain Death (DBD); a Multicenter Randomized Controlled Trial (HOPE ECD-DBD)
Brief Summary: The purpose of this study is to test the effects of hypothermic oxygenated machine perfusion (HOPE) in a phase-II prospective multicenter randomized clinical trial (RCT) on extended criteria donor allografts (ECD) in donation after brain death (DBD) orthotropic liver-transplantation (OLT) (HOPE-ECD-DBD). Human whole organ liver grafts will be submitted to 1-2 hours of HOPE via the portal vein directly before implantation and going to be compared to a control-group of patients transplanted after conventional cold storage (CCS). Primary (early graft injury) and secondary (e.g. postoperative complications, hospital stay, survival) objectives are going to be analysed in a 12 month follow up. Ischemia-reperfusion (I/R) injury and inflammation will be assessed using liver tissue, serum and bile samples as well as machine perfusion perfusate.

To improve the availability of donor allografts and reduce waiting list mortality, graft acceptance criteria were extended increasingly over the decades. The use of extended criteria donor (ECD) allografts is associated with higher incidences of primary graft non-function (PNF) and/or delayed graft function (DGF). As such, several strategies have been developed aiming at "reconditioning" poor quality ECD grafts. HOPE has been tested intensively in pre-clinical animal experiments. Although, its known that HOPE can exert its reconditioning effect via cellular and mitochondrial pathways in the endothelial and parenchymal cells, there is still scarce evidence available on the exact subcellular mechanism of HOPE induced organ protection in the clinical scenario of liver transplantation. In donation after cardiac death (DCD) OLT, the positive effects of HOPE have been shown to reduce the incidence of biliary complications, mitochondrial damage and improve the overall cellular energy-status.

In the HOPE setting, organ perfusion is performed in the transplant center shortly before the actual implantation with oxygenated perfusate using an extra corporal organ perfusion system. The first clinical study with this promising technique was recently reported in a Swiss cohort of patients who received DCD allografts. In organ donation after brain death (DBD), the only legally accepted approach for organ donation in most countries, HOPE and its effect on early graft injury and postoperative complications remains to be elucidated.


Options:
A: Arm Label: Kidney-Hypothermic oxygenated; Type: EXPERIMENTAL; Interventions: Device: Kidney-Hypothermic oxygenated | Arm Label: Kidney-Static Cold Storage; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Liver-Hypothermic oxygenated; Type: EXPERIMENTAL; Interventions: Device: Liver-Hypothermic oxygenated | Arm Label: Liver-Static Cold Storage; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Kidney-Hypothermic oxygenated; Assigned to Arm(s): Kidney-Hypothermic oxygenated | Intervention Type: DEVICE; Name: Liver-Hypothermic oxygenated; Assigned to Arm(s): Liver-Hypothermic oxygenated
B: Arm Label: Experimental: Hypothermic Machine Perfusion Group; Type: EXPERIMENTAL; Interventions: Device: The Medtronic Portable Bypass System (PBS®) | Arm Label: Matched control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: The Medtronic Portable Bypass System (PBS®); Assigned to Arm(s): Experimental: Hypothermic Machine Perfusion Group
C: 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)
D: Arm Label: Hypothermic oxygenated perfusion (HOPE); Type: ACTIVE_COMPARATOR; Interventions: Device: Hypothermic oxygenated perfusion (HOPE) | Arm Label: Control group: no intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Hypothermic oxygenated perfusion (HOPE); Assigned to Arm(s): Hypothermic oxygenated perfusion (HOPE)

Answer: C