Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2013 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Cyrill Hornuss, Ludwig-Maximilians - University of Munich Identifier:
First received: January 16, 2012
Last updated: November 11, 2013
Last verified: November 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.

Subarachnoid Hemorrhage

Study Type: Observational
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.

Resource links provided by NLM:

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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:

    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)

  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
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)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after acute SAH admitted to neurosurgical ICU

Inclusion Criteria:

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

Exclusion Criteria:

- AGE < 18

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Please refer to this study by its identifier: NCT01516671

Klinikum der Universität München
München, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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
  More Information


Responsible Party: Cyrill Hornuss, Study Principal Investigator, Ludwig-Maximilians - University of Munich Identifier: NCT01516671     History of Changes
Other Study ID Numbers: LMU-XX2011
Study First Received: January 16, 2012
Last Updated: November 11, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
Subarachnoid hemorrhage
Cerebral vasospasm
Bilateral Bispectral Index

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases processed this record on November 25, 2015