Evaluation of Celsior® in Liver Transplant Preservation.

November 22, 2007 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
      • Créteil, France, 94010
        • Service de Chirurgie Digestive - Hôpital Henri Mondor
      • Limoges, France, 87042
        • Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren
      • Lyon, France, 69317
        • Chirurgie Générale et Digestive - Hôpital de La Croix Rousse
      • Lyon, France, 69437
        • Service de Chirurgie Générale - Hôpital Edouard Herriot
      • Marseille, France, 13385
        • Service de Chirurgie Générale - Hôpital de la Conception
      • Paris, France, 75679
        • Service de Chirurgie Générale et Digestive - Hôpital Cochin
      • Rennes, France, 35033
        • Département de Chirurgie Viscérale - Hôpital Pontchaillou
      • Strasbourg, France, 67098
        • Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Celsior preservation solution
Other: Celsior®
Graft preservation solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft failure leading to patient death or retransplantation
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Sangstat Medical Corporation

Investigators

  • Study Director: Karim Boudjema, MD, PhD, Chu Rennes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

November 26, 2007

Last Update Submitted That Met QC Criteria

November 22, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AFSSAPS 020007
  • LOC-H/01-04
  • CIC0203/006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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