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Completed

NCT Number: NCT00151593

Evaluation of Celsior® in Liver Transplant Preservation.

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celsior®

Other

Graft preservation solution

Primary outcomes

  1. Graft failure leading to patient death or retransplantation

    Time frame: 1 year

Secondary outcomes

  1. Onset and severity of hemodynamic troubles at reperfusion

    Time frame: Reperfusion after transplantation

  2. Onset of surgical complications

    Time frame: 1 year

  3. Liver graft function during the fourteen first days

    Time frame: 14 days

  4. Incidence, treatment and evolution of acute and chronic rejections histologically proven

    Time frame: 1 year

  5. Onset of infections

    Time frame: 1 year

  6. Onset, treatment and evolution of serious adverse events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Sangstat Medical Corporation

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Nov 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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