Working... Menu
Trial record 98 of 195 for:    Hemorrhage AND SAH

Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Cyrill Hornuss, 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.

Condition or disease
Subarachnoid Hemorrhage

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
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.
Study Start Date : November 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Primary Outcome Measures :
  1. 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:

    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)

  2. 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.

Secondary Outcome Measures :
  1. 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
Cerebrospinal fluid Blood

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01516671

Layout table for location information
Klinikum der Universität München
München, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Layout table for investigator information
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


Layout table for additonal information
Responsible Party: Cyrill Hornuss, Study Principal Investigator, Ludwig-Maximilians - University of Munich Identifier: NCT01516671     History of Changes
Other Study ID Numbers: LMU-XX2011
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

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

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