NCT00151593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2002

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

September 8, 2005

Last Update Submit

November 22, 2007

Conditions

Liver Transplantation

Keywords

Cold storageLiver transplantationPreservation solution

Outcome Measures

Primary Outcomes (1)

  • Graft failure leading to patient death or retransplantation

    1 year

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Celsior preservation solution

Other: Celsior®

Interventions

Celsior®OTHER

Graft preservation solution

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult
  • Primary liver transplantation
  • Whole organ transplantation
  • Agreement for a 1 year follow-up
  • Informed written consent

You may not qualify if:

  • Liver disease secondary to clotting abnormalities
  • Uncontrolled bacterial or viral disease at the time of transplantation
  • Combined transplantations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de Chirurgie Digestive - Hôpital de la Côte de Nacre

Caen, 14033, France

Location

Service de Chirurgie Digestive - Hôpital Henri Mondor

Créteil, 94010, France

Location

Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren

Limoges, 87042, France

Location

Chirurgie générale et digestive - Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Service de Chirurgie Générale - Hôpital Edouard Herriot

Lyon, 69437, France

Location

Service de Chirurgie Générale - Hôpital de la Conception

Marseille, 13385, France

Location

Service de Chirurgie Générale et Digestive - Hôpital Cochin

Paris, 75679, France

Location

Département de Chirurgie Viscérale - Hôpital Pontchaillou

Rennes, 35033, France

Location

Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

Strasbourg, 67098, France

Location

Related Publications (2)

  • 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.

    PMID: 15910289BACKGROUND

  • 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.

    PMID: 10968434BACKGROUND

MeSH Terms

Interventions

Celsior

Study Officials

  • Karim Boudjema, MD, PhD

    CHU Rennes

    STUDY DIRECTOR

  • Eric Bellissant, MD, PhD

    CHU Rennes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

February 1, 2002

Study Completion

March 1, 2006

Last Updated

November 26, 2007

Record last verified: 2007-11

Locations

FR(9)