Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

• Conditions: Subarachnoid Hemorrhage

• Registration Number: NCT01516671
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Admission to neurosurgical ICU Klinikum der Universität München
• SAH
• External CSF drainage

Exclusion Criteria

• AGE < 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bilateral Bispectral Index	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.
Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood.	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: 1. Anandamide; 2. 2-arachidonoylglycerol; 3. 2-arachidonoylglycerol-ether; 4. N-arachidonoyldopamine; 5. N-arachidonylglycine; 6. O-arachidonylethanolamide; 7. Palmitoylethanolamide; 8. Cortisol; 9. Corticotropin-releasing hormone (in CSF only); 10. Corticosteroid-binding globulin (in blood only)

Secondary Outcome Measures

Name	Time	Method
Transcranial Doppler	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

Trial Locations

Locations (1)

Klinikum der Universität München; 🇩🇪 München, Germany