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Evaluation of Celsior® in Liver Transplant Preservation.

NCT ID: NCT00151593

Last Updated: 2007-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2006-03-31

Brief Summary

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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

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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).

Conditions

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Liver Transplantation

Keywords

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Cold storage Liver transplantation Preservation solution

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Celsior preservation solution

Group Type EXPERIMENTAL

Celsior®

Intervention Type OTHER

Graft preservation solution

Interventions

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Celsior®

Graft preservation solution

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sangstat Medical Corporation

INDUSTRY

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Karim Boudjema, MD, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Eric Bellissant, MD, PhD

Role: STUDY_CHAIR

CHU Rennes

Locations

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Service de Chirurgie Digestive - Hôpital de la Côte de Nacre

Caen, , France

Site Status

Service de Chirurgie Digestive - Hôpital Henri Mondor

Créteil, , France

Site Status

Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren

Limoges, , France

Site Status

Chirurgie générale et digestive - Hôpital de la Croix Rousse

Lyon, , France

Site Status

Service de Chirurgie Générale - Hôpital Edouard Herriot

Lyon, , France

Site Status

Service de Chirurgie Générale - Hôpital de la Conception

Marseille, , France

Site Status

Service de Chirurgie Générale et Digestive - Hôpital Cochin

Paris, , France

Site Status

Département de Chirurgie Viscérale - Hôpital Pontchaillou

Rennes, , France

Site Status

Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

Strasbourg, , France

Site Status

Countries

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France

References

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Karam G, Compagnon P, Hourmant M, Despins P, Duveau D, Noury D, Boudjema K. A single solution for multiple organ procurement and preservation. Transpl Int. 2005 Jun;18(6):657-63. doi: 10.1111/j.1432-2277.2005.00083.x.

Reference Type BACKGROUND
PMID: 15910289 (View on PubMed)

Adam R, Cailliez V, Majno P, Karam V, McMaster P, Caine RY, O'Grady J, Pichlmayr R, Neuhaus P, Otte JB, Hoeckerstedt K, Bismuth H. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000 Aug 19;356(9230):621-7. doi: 10.1016/s0140-6736(00)02603-9.

Reference Type BACKGROUND
PMID: 10968434 (View on PubMed)

Other Identifiers

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LOC-H/01-04

Identifier Type: -

Identifier Source: secondary_id

CIC0203/006

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS 020007

Identifier Type: -

Identifier Source: org_study_id