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Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

NCT ID: NCT01516671

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Subarachnoid Hemorrhage

Keywords

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Subarachnoid hemorrhage Cerebral vasospasm Neuroinflammation Bilateral Bispectral Index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- AGE \< 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Cyrill Hornuss

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Volker Huge, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology

Cyrill Hornuss, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology

Locations

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Klinikum der Universität München

München, , Germany

Site Status

Countries

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Germany

References

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Altay T, Smithason S, Volokh N, Rasmussen PA, Ransohoff RM, Provencio JJ. A novel method for subarachnoid hemorrhage to induce vasospasm in mice. J Neurosci Methods. 2009 Oct 15;183(2):136-40. doi: 10.1016/j.jneumeth.2009.06.027. Epub 2009 Jul 1.

Reference Type BACKGROUND
PMID: 19576247 (View on PubMed)

Huge V, Lauchart M, Magerl W, Beyer A, Moehnle P, Kaufhold W, Schelling G, Azad SC. Complex interaction of sensory and motor signs and symptoms in chronic CRPS. PLoS One. 2011 Apr 29;6(4):e18775. doi: 10.1371/journal.pone.0018775.

Reference Type BACKGROUND
PMID: 21559525 (View on PubMed)

Huge V, Lauchart M, Forderreuther S, Kaufhold W, Valet M, Azad SC, Beyer A, Magerl W. Interaction of hyperalgesia and sensory loss in complex regional pain syndrome type I (CRPS I). PLoS One. 2008 Jul 23;3(7):e2742. doi: 10.1371/journal.pone.0002742.

Reference Type BACKGROUND
PMID: 18648647 (View on PubMed)

Provencio JJ, Altay T, Smithason S, Moore SK, Ransohoff RM. Depletion of Ly6G/C(+) cells ameliorates delayed cerebral vasospasm in subarachnoid hemorrhage. J Neuroimmunol. 2011 Mar;232(1-2):94-100. doi: 10.1016/j.jneuroim.2010.10.016. Epub 2010 Nov 6.

Reference Type BACKGROUND
PMID: 21059474 (View on PubMed)

Lin CL, Dumont AS, Calisaneller T, Kwan AL, Hwong SL, Lee KS. Monoclonal antibody against E selectin attenuates subarachnoid hemorrhage-induced cerebral vasospasm. Surg Neurol. 2005 Sep;64(3):201-5; discussion 205-6. doi: 10.1016/j.surneu.2005.04.038.

Reference Type BACKGROUND
PMID: 16099244 (View on PubMed)

Wolf SA, Tauber S, Ullrich O. CNS immune surveillance and neuroinflammation: endocannabinoids keep control. Curr Pharm Des. 2008;14(23):2266-78. doi: 10.2174/138161208785740090.

Reference Type BACKGROUND
PMID: 18781977 (View on PubMed)

Tischner D, Reichardt HM. Glucocorticoids in the control of neuroinflammation. Mol Cell Endocrinol. 2007 Sep 15;275(1-2):62-70. doi: 10.1016/j.mce.2007.03.007. Epub 2007 May 4.

Reference Type BACKGROUND
PMID: 17555867 (View on PubMed)

Annane D, Bellissant E, Bollaert PE, Briegel J, Confalonieri M, De Gaudio R, Keh D, Kupfer Y, Oppert M, Meduri GU. Corticosteroids in the treatment of severe sepsis and septic shock in adults: a systematic review. JAMA. 2009 Jun 10;301(22):2362-75. doi: 10.1001/jama.2009.815.

Reference Type BACKGROUND
PMID: 19509383 (View on PubMed)

Other Identifiers

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LMU-XX2011

Identifier Type: -

Identifier Source: org_study_id