NCT01187420

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

March 31, 2010

Last Update Submit

February 10, 2017

Conditions

Cerebral VasospasmDelayed Cerebral IschemiaSubarachnoid Hemorrhage

Keywords

Cerebral vasospasmdelayed cerebral ischemia (DCI)subarachnoid hemorrhage (SAH) patients

Outcome Measures

Primary Outcomes (1)

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

    10 days stay at the NSICU

Secondary Outcomes (1)

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

    10 days stay at the NSICU

Study Arms (1)

EEG and Cerebral Vasospasm

Cerebral Vasospasm and role of BIS vista monitor in Subarachnoid Hemorrhage (SAH) patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurosurgical ICU patients with Subarachnoid Hemorrhage

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (16)

  • 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.

    PMID: 14609158BACKGROUND

  • 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.

    PMID: 8023347BACKGROUND

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

    PMID: 16759442BACKGROUND

  • 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.

    PMID: 6651248BACKGROUND

  • 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.

    PMID: 15546778BACKGROUND

  • 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.

    PMID: 6689726BACKGROUND

  • 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.

    PMID: 11588316BACKGROUND

  • 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.

    PMID: 11546890BACKGROUND

  • 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.

    PMID: 19359629BACKGROUND

  • 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.

    PMID: 10232530BACKGROUND

  • 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.

    PMID: 16235500BACKGROUND

  • 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.

    PMID: 15805808BACKGROUND

  • 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.

    PMID: 7678386BACKGROUND

  • 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.

    PMID: 9546487BACKGROUND

  • 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.

    PMID: 1711451BACKGROUND

  • Schultz A, Siedenberg M, Grouven U, Kneif T, Schultz B. Comparison of Narcotrend Index, Bispectral Index, spectral and entropy parameters during induction of propofol-remifentanil anaesthesia. J Clin Monit Comput. 2008 Apr;22(2):103-11. doi: 10.1007/s10877-008-9111-6. Epub 2008 Feb 21.

    PMID: 18288579BACKGROUND

MeSH Terms

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stacie Deiner, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2010

First Posted

August 24, 2010

Study Start

June 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

US(1)