Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood. [ Time Frame: Once per day from day 1 until day 14 after hospital admission ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The mean velocities in middle cerebral and anterior cerebral arteries will be determined by transcranial Doppler
Biospecimen Retention: Samples With DNA
Cerebrospinal fluid Blood
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Subarachnoid hemorrhage (SAH) or bleeding in the brain is a form of stroke. SAH mostly results from ruptured aneurysms. This severe disease often results in death or severe physical or cognitive disabilities and reduced quality of life. One frequent complication after SAH is cerebral vasospasm, a spasm of the big arteries accompanied by infarction of healthy brain tissue. The pathophysiologic processes which drive vasospasm remain unclear. This study aims to examine the role of endocannabinoids and cortisol in cerebrospinal fluid during the development of cerebral vasospasm. Additionally, this study examines whether side difference in the processed electroencephalogram (bilateral bispectral index) may be useful for early detection of cerebral vasospasm.
Please refer to this study by its ClinicalTrials.gov identifier: 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|