Evaluation of Celsior® in Liver Transplant Preservation.

R

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)

140 participants in 1 patient group

1
Experimental group
Description:
Celsior preservation solution
Treatment:
Other: Celsior®

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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