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Evaluation of Celsior® in Liver Transplant Preservation.

This study has been completed.
Sponsor:
Collaborator:
Sangstat Medical Corporation
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151593
First received: September 8, 2005
Last updated: November 22, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
 Other: Celsior®
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Graft failure leading to patient death or retransplantation [ Time Frame: 1 year ]

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

Enrollment: 140
Study Start Date: February 2002
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: 1
Celsior preservation solution
 Other: Celsior®
Graft preservation solution

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151593

Locations
France
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
Caen, France, 14033
Service de Chirurgie Digestive - Hôpital Henri Mondor
Créteil, France, 94010
Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren
Limoges, France, 87042
Chirurgie générale et digestive - Hôpital de la Croix Rousse
Lyon, France, 69317
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, France, 69437
Service de Chirurgie Générale - Hôpital de la Conception
Marseille, France, 13385
Service de Chirurgie Générale et Digestive - Hôpital Cochin
Paris, France, 75679
Département de Chirurgie Viscérale - Hôpital Pontchaillou
Rennes, France, 35033
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, France, 67098
Sponsors and Collaborators
Rennes University Hospital
Sangstat Medical Corporation
Investigators
Study Director: Karim Boudjema, MD, PhD CHU Rennes
Study Chair: Eric Bellissant, MD, PhD CHU Rennes
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00151593     History of Changes
Other Study ID Numbers: AFSSAPS 020007, LOC-H/01-04, CIC0203/006
Study First Received: September 8, 2005
Last Updated: November 22, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Cold storage
Liver transplantation
Preservation solution

ClinicalTrials.gov processed this record on June 18, 2013