Evaluation of Celsior® in Liver Transplant Preservation.

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151593
• Other study ID #: AFSSAPS 020007
• Secondary ID: LOC-H/01-04CIC02
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: November 22, 2007
• Start date: February 2002
• Est. completion date: March 2006

Study information

• Verified date: November 2007
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Other:
• Celsior®
Graft preservation solution

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive - Hôpital de la Côte de Nacre	Caen
France	Service de Chirurgie Digestive - Hôpital Henri Mondor	Créteil
France	Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren	Limoges
France	Chirurgie générale et digestive - Hôpital de la Croix Rousse	Lyon
France	Service de Chirurgie Générale - Hôpital Edouard Herriot	Lyon
France	Service de Chirurgie Générale - Hôpital de la Conception	Marseille
France	Service de Chirurgie Générale et Digestive - Hôpital Cochin	Paris
France	Département de Chirurgie Viscérale - Hôpital Pontchaillou	Rennes
France	Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Sangstat Medical Corporation

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Erratum in: Lancet 2001 Apr 21;367(9264):1296. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft failure leading to patient death or retransplantation		1 year
Secondary	Onset and severity of hemodynamic troubles at reperfusion		Reperfusion after transplantation
Secondary	Onset of surgical complications		1 year
Secondary	Liver graft function during the fourteen first days		14 days
Secondary	Incidence, treatment and evolution of acute and chronic rejections histologically proven		1 year
Secondary	Onset of infections		1 year
Secondary	Onset, treatment and evolution of serious adverse events		1 year