Evaluation of Celsior® in Liver Transplant Preservation.

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151593

Enrollment

140

Registered

2005-09-09

Start date

2002-02-28

Completion date

2006-03-31

Last updated

2007-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Cold storage, Liver transplantation, Preservation solution

Brief 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).

Interventions

OTHERCelsior®

Graft preservation solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Graft failure leading to patient death or retransplantation	1 year

Secondary

Measure	Time frame
Onset of surgical complications	1 year
Liver graft function during the fourteen first days	14 days
Onset and severity of hemodynamic troubles at reperfusion	Reperfusion after transplantation
Onset of infections	1 year
Onset, treatment and evolution of serious adverse events	1 year
Incidence, treatment and evolution of acute and chronic rejections histologically proven	1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026