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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00151593 |
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Date of registration:
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08/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Celsior® in Liver Transplant Preservation.
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Scientific title:
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Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation. |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00151593 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Eric Bellissant, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Rennes |
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Name:
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Karim Boudjema, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Rennes |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Transplantation
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Intervention(s)
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Other: Celsior®
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Primary Outcome(s)
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Graft failure leading to patient death or retransplantation
[Time Frame: 1 year]
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Secondary Outcome(s)
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Onset, treatment and evolution of serious adverse events
[Time Frame: 1 year]
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Incidence, treatment and evolution of acute and chronic rejections histologically proven
[Time Frame: 1 year]
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Onset and severity of hemodynamic troubles at reperfusion
[Time Frame: Reperfusion after transplantation]
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Onset of infections
[Time Frame: 1 year]
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Liver graft function during the fourteen first days
[Time Frame: 14 days]
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Onset of surgical complications
[Time Frame: 1 year]
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Secondary ID(s)
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AFSSAPS 020007
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CIC0203/006
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LOC-H/01-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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