Hypothermic Oxygenated Perfusion for Extended Criteria Donors in Liver Transplantation (HOPExt)

NACompletedINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

September 10, 2019

Primary Completion Date

March 13, 2023

Study Completion Date

March 13, 2023

Conditions
Liver Transplantation
Interventions
DEVICE

End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)

"In the experimental group, ECD liver grafts will first undergo a classical static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until transport to the transplantation center. They will then undergo a hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of 1 to 4 hours (minimum 1 hour) after the back-table phase (graft preparation), in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (Organ Assist®, the Netherlands) with Machine Perfusion Solution (Belzer-MPS, CE-certified)."

DEVICE

classic static cold storage

The control group will consist of a classic static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until liver transplantation, which is the gold standard procedure in liver transplantation

Trial Locations (8)

35033

Department of HPB surgery and liver transplantation Pontchaillou University Hospital, Rennes

38000

CHU Grenoble Alpes - Department of HPB surgery and liver transplantation, Grenoble

59037

Department of HPB surgery and liver transplantation Claude Huriez University Hospital, Lille

67200

Hôpital Hautepierre - Department of HPB surgery and liver transplantation, Strasbourg

69004

Hospices Civils de Lyon, Lyon

75013

APHP - Pitié Salpétrière, Paris

92210

Department of HPB surgery and liver transplantation Beaujon University Hospital, Clichy

94804

Department of HPB surgery and liver transplantation Paul Brousse University Hospital, Villejuif

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03929523 - Hypothermic Oxygenated Perfusion for Extended Criteria Donors in Liver Transplantation (HOPExt) | Biotech Hunter | Biotech Hunter