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Subarachnoid HemorrhageNCT01516671

Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage

An observational study of Subarachnoid Hemorrhage, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subarachnoid Hemorrhage
How many people
40 participants
Where
1 siteGermany
Study dates
Nov 2011to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients after acute SAH admitted to neurosurgical ICU

Who may be able to join

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

Who cannot join

  • AGE < 18

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum der Universität München

    München, 81377

Other trials in Germany

About this study

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.

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.

Read the 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.

Keywords
Subarachnoid hemorrhage, Cerebral vasospasm, Neuroinflammation, Bilateral Bispectral Index
Medical subject headings
Subarachnoid Hemorrhage, Vasospasm, Intracranial, Neuroinflammatory Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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.

    Measured: 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)

  1. Transcranial Doppler

    The mean velocities in middle cerebral and anterior cerebral arteries will be determined by transcranial Doppler

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516671
Sponsor's protocol ID
LMU-XX2011
Status last verified
Nov 2013
First submitted
16 Jan 2012
Last updated
13 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19576247

  • 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.

    PubMed 21559525

  • 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.

    PubMed 18648647

  • 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.

    PubMed 21059474

  • 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.

    PubMed 16099244

  • 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.

    PubMed 18781977

  • 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.

    PubMed 17555867

  • 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.

    PubMed 19509383

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood. (time frame: Once per day from day 1 until day 14 after hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516671, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.

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