Clinical trial NCT01516671: Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid hemorrhage
Cerebral vasospasm
Neuroinflammation
Bilateral Bispectral Index
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after acute SAH admitted to neurosurgical ICU

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- AGE \< 18

Primary outcomes:
measure: Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood.
timeFrame: Once per day from day 1 until day 14 after hospital admission
measure: Bilateral Bispectral Index
timeFrame: 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
Secondary outcomes:
measure: Transcranial Doppler
timeFrame: Every day at 8 am from day 1 until day 14 after hospital admission
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum der Universität München
Study officials:
affiliation: Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology
name: Volker Huge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology
name: Cyrill Hornuss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.