A Phase 2 interventional study of Celsior® in Liver Transplantation, sponsored by Rennes University Hospital. Completed at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-26.
Sponsored by Rennes University Hospital · Phase 2, Interventional, and Treatment
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).
Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Celsior preservation solution
Other: Celsior®
Graft preservation solution
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
The record gives a start of Feb 2002 and a completion of Mar 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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