Table 2.
Overview of currently ongoing randomized control trials (RCTs) on hypothermic machine perfusion (MP) in liver transplantation.
| Group/NCT | MP and Comp. | Design | N | Donors | Perfusion 1 | Primary Endpoint |
|---|---|---|---|---|---|---|
| Zurich, Switzerland NCT01317342 |
HOPE/SCS | recruitment completed multicenter RCT | 85 vs. 85 | DBD | LiverAssist; 8–10 °C; end-ischemic HOPE, single (PV) perfusion | Major postoperative complications (Clavien grade ≥III) and CCI |
| Groningen, Netherlands NCT02584283 |
DHOPE/SCS | recruitment completed multicenter RCT | 78 vs. 78 | DCD (Maastricht category III) | LiverAssist; 8–10 °C; end-ischemic dual (PV+HA) HOPE, 2 h | Incidence of NAS |
| Aachen, Germany NCT03124641 |
HOPE/SCS | Recruiting multicenter RCT | 23 vs. 23 | ECD-DBD | LiverAssist; 8–10 °C; end-ischemic HOPE, single (PV) perfusion, 1(–2) h | Early graft injury (peak ALT level) |
| New Jersey, USA NCT03484455 |
HMP/SCS | Recruiting multicenter RCT | 70 vs. 70 | Not stated | LifePort Liver Transporter, Temperature not stated; preservation HMP, dual perfusion from retrieval to implantation, no active oxygenation, 3–7 h | Early allograft dysfunction (EAD) |
| Lyon, France NCT03929523 |
HMP/SCS | Recruiting multicenter RCT | 133 vs. 133 | ECD-DBD | LiverAssist; 8–10 °C; end-ischemic HOPE, single (PV) perfusion, 1(–2) h | Early allograft dysfunction (EAD) |
1 Listed perfusion devices: LiverAssist, Organ Assist (Groningen, The Netherlands); LifePort Liver Transporter, Organ Recovery Systems (Chicago, IL, USA). Abbreviations: RCT, randomized controlled trial; CCI, comprehensive complication index; ALT, alanine aminotransferase; DBD, donation after brain death; DCD, donation after circulatory death; d-HOPE, dual hypothermic oxygenated machine perfusion; EAD, early allograft dysfunction; ECD, extended criteria donation; HA, hepatic artery; HOPE, hypothermic oxygenated machine perfusion; MP, machine perfusion; NAS, non-anastomotic biliary strictures; PV, portal vein; SCS, static cold storage.