Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyrill Hornuss, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01516671
First received: January 16, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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
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.

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.

  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- AGE < 18

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516671

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

Publications:

Responsible Party: Cyrill Hornuss, Study Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov 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
Neuroinflammation
Bilateral Bispectral Index

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 10, 2014