Liver Transplantation Clinical Trial
Official title:
Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.
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).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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