Clinical trial NCT00151593: Evaluation of Celsior® in Liver Transplant Preservation.
Official title: Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplantation
Keywords: Cold storage
Liver transplantation
Preservation solution
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Sangstat Medical Corporation
First posted: 2005-09-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Adult
* Primary liver transplantation
* Whole organ transplantation
* Agreement for a 1 year follow-up
* Informed written consent

Exclusion Criteria:

* Liver disease secondary to clotting abnormalities
* Uncontrolled bacterial or viral disease at the time of transplantation
* Combined transplantations

Primary outcomes:
measure: Graft failure leading to patient death or retransplantation
timeFrame: 1 year
Secondary outcomes:
measure: Onset and severity of hemodynamic troubles at reperfusion
timeFrame: Reperfusion after transplantation
measure: Onset of surgical complications
timeFrame: 1 year
measure: Liver graft function during the fourteen first days
timeFrame: 14 days
measure: Incidence, treatment and evolution of acute and chronic rejections histologically proven
timeFrame: 1 year
measure: Onset of infections
timeFrame: 1 year
measure: Onset, treatment and evolution of serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
city: Créteil
country: France
facility: Service de Chirurgie Digestive - Hôpital Henri Mondor
city: Limoges
country: France
facility: Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren
city: Lyon
country: France
facility: Chirurgie générale et digestive - Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Service de Chirurgie Générale - Hôpital Edouard Herriot
city: Marseille
country: France
facility: Service de Chirurgie Générale - Hôpital de la Conception
city: Paris
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital Cochin
city: Rennes
country: France
facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Study officials:
affiliation: CHU Rennes
name: Karim Boudjema, MD, PhD
role: STUDY_DIRECTOR
affiliation: CHU Rennes
name: Eric Bellissant, MD, PhD
role: STUDY_CHAIR
References:
citation: Karam G, Compagnon P, Hourmant M, Despins P, Duveau D, Noury D, Boudjema K. A single solution for multiple organ procurement and preservation. Transpl Int. 2005 Jun;18(6):657-63. doi: 10.1111/j.1432-2277.2005.00083.x.
citation: Adam R, Cailliez V, Majno P, Karam V, McMaster P, Caine RY, O'Grady J, Pichlmayr R, Neuhaus P, Otte JB, Hoeckerstedt K, Bismuth H. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000 Aug 19;356(9230):621-7. doi: 10.1016/s0140-6736(00)02603-9.