NCT00151593

Evaluation of Celsior® in Liver Transplant Preservation.

Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
OTHER	Celsior®	Graft preservation solution

Timeline

• Start date: 2002-02-01
• Completion: 2006-03-01
• First posted: 2005-09-09
• Last updated: 2007-11-26

Locations

9 sites across 1 country: France