Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01516671
• Other study ID #: LMU-XX2011
• Status: Active, not recruiting
• Phase: N/A
• First received: January 16, 2012
• Last updated: November 11, 2013
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to neurosurgical ICU Klinikum der Universität München

• SAH

• External CSF drainage

Exclusion Criteria:

• AGE < 18

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
Germany	Klinikum der Universität München	München

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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. — View 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. Review. — View Citation

Huge V, Lauchart M, Förderreuther 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. — View 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. — View 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. — View 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. — View Citation

Tischner D, Reichardt HM. Glucocorticoids in the control of neuroinflammation. Mol Cell Endocrinol. 2007 Sep 15;275(1-2):62-70. Epub 2007 May 4. Review. — View Citation

Wolf SA, Tauber S, Ullrich O. CNS immune surveillance and neuroinflammation: endocannabinoids keep control. Curr Pharm Des. 2008;14(23):2266-78. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood.	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: Anandamide; 2-arachidonoylglycerol; 2-arachidonoylglycerol-ether; N-arachidonoyldopamine; N-arachidonylglycine; O-arachidonylethanolamide; Palmitoylethanolamide; Cortisol; Corticotropin-releasing hormone (in CSF only); Corticosteroid-binding globulin (in blood only)	Once per day from day 1 until day 14 after hospital admission	No
Primary	Bilateral Bispectral Index	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.	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	No
Secondary	Transcranial Doppler	The mean velocities in middle cerebral and anterior cerebral arteries will be determined by transcranial Doppler	Every day at 8 am from day 1 until day 14 after hospital admission	No