Evaluation of Celsior® in Liver Transplant Preservation.

Phase 2

Completed

• Conditions: Liver Transplantation
• Interventions: Other: Celsior®

• Registration Number: NCT00151593
• Lead Sponsor: Rennes University Hospital

Brief 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.

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 Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Study Completion: 2006-03
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-22
• Last Update Posted: 2007-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Celsior®	Celsior preservation solution

Primary Outcome Measures

Name	Time	Method
Graft failure leading to patient death or retransplantation	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Service de Chirurgie Générale - Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Service de Chirurgie Générale - Hôpital de la Conception; 🇫🇷 Marseille, France

Chirurgie générale et digestive - Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Service de Chirurgie Digestive - Hôpital Henri Mondor; 🇫🇷 Créteil, France

Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre; 🇫🇷 Strasbourg, France

Département de Chirurgie Viscérale - Hôpital Pontchaillou; 🇫🇷 Rennes, France

Service de Chirurgie Digestive - Hôpital de la Côte de Nacre; 🇫🇷 Caen, France

Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren; 🇫🇷 Limoges, France

Service de Chirurgie Générale et Digestive - Hôpital Cochin; 🇫🇷 Paris, France