Evaluation of Celsior® in Liver Transplant Preservation.

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: Liver Transplantation
• Intervention / Treatment: Other: Celsior®

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

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Sangstat Medical Corporation
• Investigators: Study Director: Karim Boudjema, MD, PhD, CHU Rennes

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Lancet 2001 Apr 21;367(9264):1296.

Study record dates

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: Liver transplantation; Cold storage; Preservation solution
• Other Study ID Numbers: AFSSAPS 020007; LOC-H/01-04; CIC0203/006