Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

NCT01516671 | Unknown

• 1 other identifier: LMU-XX2011
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid hemorrhage; Cerebral vasospasm; Neuroinflammation; Bilateral Bispectral Index

Outcome Measures

Primary Outcomes (2)

• 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: 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)

  Once per day from day 1 until day 14 after hospital admission

• 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

Secondary Outcomes (1)

• Transcranial Doppler

  Every day at 8 am from day 1 until day 14 after hospital admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after acute SAH admitted to neurosurgical ICU

You may qualify if:

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

You may not qualify if:

• \- AGE \< 18

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Klinikum der Universität München

München, 81377, Germany

Location

Related 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.

  PMID: 19576247 BACKGROUND

• 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.

  PMID: 21559525 BACKGROUND

• 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.

  PMID: 18648647 BACKGROUND

• 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.

  PMID: 21059474 BACKGROUND

• 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.

  PMID: 16099244 BACKGROUND

• 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.

  PMID: 18781977 BACKGROUND

• 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.

  PMID: 17555867 BACKGROUND

• 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.

  PMID: 19509383 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid Blood

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 25, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

DE (1)