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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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7 April 2015 |
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Main ID: |
NCT01374633 |
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Date of registration:
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08/06/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
SEPIA |
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Scientific title:
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Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01374633 |
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Study type:
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Interventional |
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Study design:
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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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Jacques DURANTEAU, 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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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- severe traumatic brain injury (glasgow < 8)
- age > 18
- no surgery scheduled
- sedation with midazolam and sufentanil
- ICP sensor
Exclusion Criteria:
- external ventricular derivation
- pregnancy
- antecedent of malign hyperthermia
- haemodynamic instability
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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Brain Injury
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Intervention(s)
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Drug: 1: Sevoflurane
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Primary Outcome(s)
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ICP evolution
[Time Frame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane]
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Secondary Outcome(s)
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Haemodynamic tolerance
[Time Frame: during the 12 hours of sedation with sevoflurane]
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Sedation level
[Time Frame: during the 12 hours of sedation with sevoflurane]
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Malignant hyperthermia screening
[Time Frame: during the 12 hours of sedation with sevoflurane]
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Secondary ID(s)
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P100206
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2011-000253-23
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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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