Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage
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|ClinicalTrials.gov Identifier: NCT01516671|
Recruitment Status : Unknown
Verified November 2013 by Cyrill Hornuss, Ludwig-Maximilians - University of Munich.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : November 13, 2013
Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to severe disability in survivors caused by cerebral vasospasm and infarction.
This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Pilot Study on the Role of Neuroinflammation in the Pathophysiology of Subarachnoid Hemorrhage and the Value of the Bilateral Bispectral Index for Early Diagnosis of Cerebral Ischemia After Subarachnoid Hemorrhage.|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
- Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood. [ Time Frame: Once per day from day 1 until day 14 after hospital admission ]
Samples of cerebrospinal fluid and blood will be collected every day at 8am on hospital day 1-14 and the concentrations of the following substances will be determined:
- Corticotropin-releasing hormone (in CSF only)
- Corticosteroid-binding globulin (in blood only)
- Bilateral Bispectral Index [ Time Frame: Every second from 0:01 am until 23:59 pm on hospital day 1,2,3,4,5,6,7,8,9,10,11,12,13,14 ]The Bispectral Index is calculated every second by the BIS Vista monitor. These data will be recorded continuously from 0:01 am until 23:59 pm.
- Transcranial Doppler [ Time Frame: Every day at 8 am from day 1 until day 14 after hospital admission ]The mean velocities in middle cerebral and anterior cerebral arteries will be determined by transcranial Doppler
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516671
|Klinikum der Universität München|
|München, Germany, 81377|
|Principal Investigator:||Volker Huge, MD||Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology|
|Principal Investigator:||Cyrill Hornuss, MD||Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology|