Subarachnoid Hemorrhage Clinical Trial
— BISOfficial title:
Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)
Verified date | February 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult men or women of any age and ethnicity within 48 hours of subarachnoid hemorrhage (SAH) Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Aaslid R, Huber P, Nornes H. Evaluation of cerebrovascular spasm with transcranial Doppler ultrasound. J Neurosurg. 1984 Jan;60(1):37-41. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Claassen J, Mayer SA, Hirsch LJ. Continuous EEG monitoring in patients with subarachnoid hemorrhage. J Clin Neurophysiol. 2005 Apr;22(2):92-8. Review. — View Citation
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. — View Citation
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. — View Citation
Heros RC, Zervas NT, Varsos V. Cerebral vasospasm after subarachnoid hemorrhage: an update. Ann Neurol. 1983 Dec;14(6):599-608. — View Citation
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. — View Citation
Lysakowski C, Walder B, Costanza MC, Tramèr 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. — View Citation
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. — View Citation
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. — View Citation
Sehba FA, Bederson JB. Mechanisms of acute brain injury after subarachnoid hemorrhage. Neurol Res. 2006 Jun;28(4):381-98. Review. — View Citation
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. — View Citation
Towle VL, Bolaños 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. — View Citation
Vespa PM, Nuwer MR, Juhász 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. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS) | 10 days stay at the NSICU | ||
Secondary | BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm | 10 days stay at the NSICU |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Recruiting |
NCT04189471 -
Recovery After Cerebral Hemorrhage
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05131295 -
Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
|
Phase 3 | |
Recruiting |
NCT02962349 -
TRansfusion Strategies in Acute Brain INjured Patients
|
N/A | |
Completed |
NCT02872857 -
Subarachnoid Hemorrhage Recovery And Galantamine
|
Phase 1/Phase 2 | |
Terminated |
NCT02216513 -
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
|
Phase 0 | |
Completed |
NCT03164434 -
Influence of Drainage on EVD ICP-signal
|
||
Not yet recruiting |
NCT00905931 -
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
|
Phase 2 | |
Completed |
NCT01077206 -
High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage
|
Phase 2/Phase 3 | |
Completed |
NCT02389634 -
Identification of Novel Molecular Markers for Vasospasm
|
||
Completed |
NCT00962546 -
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT01261091 -
Early Tracheostomy in Ventilated Stroke Patients
|
N/A | |
Completed |
NCT00507104 -
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
|
||
Completed |
NCT00071565 -
Familial Intracranial Aneurysm Study II
|
N/A | |
Recruiting |
NCT05113381 -
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH
|
N/A | |
Completed |
NCT04052646 -
Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
|
||
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Recruiting |
NCT06033378 -
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.
|
N/A | |
Completed |
NCT04308577 -
Diet Induced Ketosis for Brain Injury - A Feasibility Study
|
N/A |