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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: |
NCT00795587 |
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Date of registration:
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20/11/2008 |
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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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Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
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Scientific title:
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Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00795587 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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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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Gilles Francony, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adults
- severe traumatic brain injury
- intracranial hypertension requiring mannitol administration
Exclusion Criteria:
- impeding neurosurgery
- hemodynamic or respiratory severe failure
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Traumatic Brain Injury
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Intracranial Hypertension
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Intervention(s)
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Drug: variation of mannitol dose
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Primary Outcome(s)
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intracranial pressure
[Time Frame: 2 hours]
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Secondary Outcome(s)
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biology (blood gases, natremia, hematocrit)
[Time Frame: 2h]
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MAP
[Time Frame: 2h]
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brain PO2
[Time Frame: 2h]
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diuresis
[Time Frame: 2h]
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fluid requirement
[Time Frame: 2h]
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Heart Rate
[Time Frame: 2h]
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transcranial doppler
[Time Frame: 2 h]
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Secondary ID(s)
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2008-004979-21
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0816
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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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