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Cerebral VasospasmBISNCT01187420

Bilateral Bispectral Index (BIS) Study

An observational study of Cerebral Vasospasm and Delayed Cerebral Ischemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess real time changes in raw and processed EEG in relation to the clinical and radiological evidence of cerebral vasospasm. Read more about this study

Who is it for?
Ages 18 years and older
How many people
30 participants
Where
1 siteUnited States
Study dates
Jun 2009to Oct 2010
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: Neurosurgical ICU patients with Subarachnoid Hemorrhage

Who may be able to join

  • Adult men or women of any age and ethnicity within 48 hours of subarachnoid hemorrhage (SAH)

Who cannot join

  • Age < 18 years
  • Greater than 48 hours past the initial hemorrhage
  • Previous history of stroke of any etiology
  • Inability to consent for themselves or have a proxy to consent for them (implied consent)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

Official title: Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)

The purpose of this study is to assess real time changes in raw and processed EEG in relation to the clinical and radiological evidence of cerebral vasospasm.

Read the detailed description

Subarachnoid hemorrhage (SAH) is a prevalent and morbid condition (45%-30 day mortality). One of the major causes of reduced cerebral blood flow (CBF) after initial SAH is cerebral vasospasm. Early treatment of cerebral vasospasm (< 2 hr) is necessary for improved neurologic outcome. Hence, there is significant interest in development of a monitor. The most common bedside diagnostic tool is Transcranial Doppler (TCD) which is controversial given its low sensitivity and specificity. TCD is not a continuous monitor and is user dependent. Many centers rely on Cerebral Angiography for diagnosis of vasospasm; however angiographic spasm does not correlate with outcome. EEG can detect changes in cerebral blood flow which precede clinical decline but is technically difficult to perform and not practical for continuous monitoring.

Processed EEG monitors have become somewhat popular in the operating setting for assessment of depth of anesthesia. The recent introduction of bilateral 4 channel disposable probes presents to opportunity to use EEG as a non-invasive continuous monitor for vasospasm. We propose a prospective observational study to assess real time changes in raw and processed EEG which we will correlate with clinical and radiologic evidence of vasospasm. Our primary clinical endpoint will be the determination of delayed cerebral ischemia. This modality could prove to be a significant clinical advantage for patients suffering from SAH.

Keywords
Cerebral vasospasm, delayed cerebral ischemia (DCI), subarachnoid hemorrhage (SAH) patients
Medical subject headings
Vasospasm, Intracranial, Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01187420
Study groupRoleWhat they receive
EEG and Cerebral VasospasmCerebral Vasospasm and role of BIS vista monitor in Subarachnoid Hemorrhage (SAH) patients

What is being measured

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

  1. Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS)

    Measured: 10 days stay at the NSICU

Secondary outcomes (1)

  1. BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm

    Measured: 10 days stay at the NSICU

Timeline

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

  1. First posted24 Aug 2010 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2010
  4. Study completionOct 2010

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187420
Sponsor's protocol ID
09-0470
Acronym
BIS
Status last verified
Feb 2017
First submitted
31 Mar 2010
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Cross DT 3rd, Tirschwell DL, Clark MA, Tuden D, Derdeyn CP, Moran CJ, Dacey RG Jr. Mortality rates after subarachnoid hemorrhage: variations according to hospital case volume in 18 states. J Neurosurg. 2003 Nov;99(5):810-7. doi: 10.3171/jns.2003.99.5.0810.

    PubMed 14609158

  • Broderick JP, Brott TG, Duldner JE, Tomsick T, Leach A. Initial and recurrent bleeding are the major causes of death following subarachnoid hemorrhage. Stroke. 1994 Jul;25(7):1342-7. doi: 10.1161/01.str.25.7.1342.

    PubMed 8023347

  • Sehba FA, Bederson JB. Mechanisms of acute brain injury after subarachnoid hemorrhage. Neurol Res. 2006 Jun;28(4):381-98. doi: 10.1179/016164106X114991.

    PubMed 16759442

  • Heros RC, Zervas NT, Varsos V. Cerebral vasospasm after subarachnoid hemorrhage: an update. Ann Neurol. 1983 Dec;14(6):599-608. doi: 10.1002/ana.410140602.

    PubMed 6651248

  • Claassen J, Hirsch LJ, Kreiter KT, Du EY, Connolly ES, Emerson RG, Mayer SA. Quantitative continuous EEG for detecting delayed cerebral ischemia in patients with poor-grade subarachnoid hemorrhage. Clin Neurophysiol. 2004 Dec;115(12):2699-710. doi: 10.1016/j.clinph.2004.06.017.

    PubMed 15546778

  • Aaslid R, Huber P, Nornes H. Evaluation of cerebrovascular spasm with transcranial Doppler ultrasound. J Neurosurg. 1984 Jan;60(1):37-41. doi: 10.3171/jns.1984.60.1.0037.

    PubMed 6689726

  • Lysakowski C, Walder B, Costanza MC, Tramer MR. Transcranial Doppler versus angiography in patients with vasospasm due to a ruptured cerebral aneurysm: A systematic review. Stroke. 2001 Oct;32(10):2292-8. doi: 10.1161/hs1001.097108.

    PubMed 11588316

  • Claassen J, Bernardini GL, Kreiter K, Bates J, Du YE, Copeland D, Connolly ES, Mayer SA. Effect of cisternal and ventricular blood on risk of delayed cerebral ischemia after subarachnoid hemorrhage: the Fisher scale revisited. Stroke. 2001 Sep;32(9):2012-20. doi: 10.1161/hs0901.095677.

    PubMed 11546890

  • Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Connolly ES, Mayer SA. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke. 2009 Jun;40(6):1963-8. doi: 10.1161/STROKEAHA.108.544700. Epub 2009 Apr 9.

    PubMed 19359629

  • Rosenwasser RH, Armonda RA, Thomas JE, Benitez RP, Gannon PM, Harrop J. Therapeutic modalities for the management of cerebral vasospasm: timing of endovascular options. Neurosurgery. 1999 May;44(5):975-9; discussion 979-80. doi: 10.1097/00006123-199905000-00022.

    PubMed 10232530

  • Sen I, Puri GD, Bapuraj JR. Early detection of cerebral vasospasm during a neurointerventional procedure using the BIS. Anaesth Intensive Care. 2005 Oct;33(5):691-2. No abstract available.

    PubMed 16235500

  • Claassen J, Mayer SA, Hirsch LJ. Continuous EEG monitoring in patients with subarachnoid hemorrhage. J Clin Neurophysiol. 2005 Apr;22(2):92-8. doi: 10.1097/01.wnp.0000145006.02048.3a.

    PubMed 15805808

  • Towle VL, Bolanos J, Suarez D, Tan K, Grzeszczuk R, Levin DN, Cakmur R, Frank SA, Spire JP. The spatial location of EEG electrodes: locating the best-fitting sphere relative to cortical anatomy. Electroencephalogr Clin Neurophysiol. 1993 Jan;86(1):1-6. doi: 10.1016/0013-4694(93)90061-y.

    PubMed 7678386

  • Vespa PM, Nuwer MR, Juhasz C, Alexander M, Nenov V, Martin N, Becker DP. Early detection of vasospasm after acute subarachnoid hemorrhage using continuous EEG ICU monitoring. Electroencephalogr Clin Neurophysiol. 1997 Dec;103(6):607-15. doi: 10.1016/s0013-4694(97)00071-0.

    PubMed 9546487

  • Labar DR, Fisch BJ, Pedley TA, Fink ME, Solomon RA. Quantitative EEG monitoring for patients with subarachnoid hemorrhage. Electroencephalogr Clin Neurophysiol. 1991 May;78(5):325-32. doi: 10.1016/0013-4694(91)90094-k.

    PubMed 1711451

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Vasospasm and Delayed Cerebral Ischemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

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 1 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2017. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS) (time frame: 10 days stay at the NSICU). 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 NCT01187420, which also lists 16 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 Feb 2017.

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