The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.
The quality of organ preservation is a major determinant of initial graft function and survival. Graft viability is based on hypothermia, the organ being stored in a cold preservation solution. Celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. The aim of the study is to evaluate the efficacy and safety of Celsior® in liver transplant preservation. Celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the European transplantation register between 1997 and 2001).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Graft preservation solution
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
Caen, France
Service de Chirurgie Digestive - Hôpital Henri Mondor
Créteil, France
Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren
Limoges, France
Graft failure leading to patient death or retransplantation
Time frame: 1 year
Onset and severity of hemodynamic troubles at reperfusion
Time frame: Reperfusion after transplantation
Onset of surgical complications
Time frame: 1 year
Liver graft function during the fourteen first days
Time frame: 14 days
Incidence, treatment and evolution of acute and chronic rejections histologically proven
Time frame: 1 year
Onset of infections
Time frame: 1 year
Onset, treatment and evolution of serious adverse events
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chirurgie générale et digestive - Hôpital de la Croix Rousse
Lyon, France
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, France
Service de Chirurgie Générale - Hôpital de la Conception
Marseille, France
Service de Chirurgie Générale et Digestive - Hôpital Cochin
Paris, France
Département de Chirurgie Viscérale - Hôpital Pontchaillou
Rennes, France
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, France