Evaluation of Celsior® in Liver Transplant Preservation.

Rennes University Hospital

Status and phase: Completed; Phase 2

Conditions: Liver Transplantation

Treatments: Other: Celsior®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00151593

CIC0203/006

AFSSAPS 020007

LOC-H/01-04

Details and patient eligibility

About

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.

Full 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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

1

Experimental group

Description:

Celsior preservation solution

Treatment:

Other: Celsior®