Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department (READ-TBI)
18. april 2016 oppdatert av: BrainScope Company, Inc.
Use Of A Point-Of-Care TBI Detection System For Identification Of Head Injured Patients Who Present To The Emergency Department
A prospective, non-randomized trial for the extension and replication of the development database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.
Studieoversikt
Detaljert beskrivelse
The objective of this study is to test the clinical utility of the BrainScope technology for the acute identification of traumatic structural brain injury in the TBI population, following closed head injury.
The data generated will serve to validate and/or refine the current algorithms to detect acute, traumatic, structural brain injury.
Studietype
Observasjonsmessig
Registrering (Faktiske)
421
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Connecticut
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Hartford, Connecticut, Forente stater, 06102
- Hartford Hospital
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Georgia
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Atlanta, Georgia, Forente stater, 30303
- Emory University- Grady Hospital
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- R Cowley Shock Trauma Hospital
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Michigan
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Detroit, Michigan, Forente stater, 48235
- Wayne State University - Sinai Grace Hospital
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Detroit, Michigan, Forente stater, 48235
- Wayne State University - Detroit Receiving Hospital
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Missouri
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St. Louis, Missouri, Forente stater, 63110
- Washington University - Barnes Jewish Hospital
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New York
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Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny General Hospital
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Texas
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Dallas, Texas, Forente stater, 75246
- Baylor University Medical Center
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Houston, Texas, Forente stater, 77030
- UT-Houston Health Science Center
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects who are suspected of a traumatic, closed head injury within 24 hours will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study.
Beskrivelse
Inclusion Criteria:
- Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 24 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).
Exclusion Criteria:
- Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
In addition,
- subjects with dementia,
- Parkinson's Disease,
- multiple sclerosis,
- seizure disorder,
- brain tumors,
- history of brain surgery,
- psychiatric disorder being managed by a psychiatric healthcare professional/provider,
- substance dependence,
- history of TIA or stroke within the last year,
- currently receiving dialysis or in end-stage renal disease,
- active fever defined as greater than 100 degrees F or 37.7 degrees C,
- current condition is "critical" in the opinion of the investigator,
- subject is suffering from an open head injury,
- subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications.
- Subjects below the age of 18 years, and prisoners will not be eligible for study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Extend and replicate a database of brain electrical activity and clinical information collected from patients who present to the ED following closed head injury
Tidsramme: 30 days
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30 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Douglas C Oberly, BrainScope Company, Inc.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Huff JS, Jahar S. Differences in interpretation of cranial computed tomography in ED traumatic brain injury patients by expert neuroradiologists. Am J Emerg Med. 2014 Jun;32(6):606-8. doi: 10.1016/j.ajem.2014.03.010. Epub 2014 Mar 18.
- O'Neil B, Naunheim R, DeLorenzo R. CT positive brain injury in mild TBI patients presenting with normal SAC scores. Mil Med. 2014 Nov;179(11):1250-3. doi: 10.7205/MILMED-D-13-00585.
- Prichep LS, Jacquin A, Filipenko J, Dastidar SG, Zabele S, Vodencarevic A, Rothman NS. Classification of traumatic brain injury severity using informed data reduction in a series of binary classifier algorithms. IEEE Trans Neural Syst Rehabil Eng. 2012 Nov;20(6):806-22. doi: 10.1109/TNSRE.2012.2206609. Epub 2012 Jul 26.
- Prichep LS, Ghosh Dastidar S, Jacquin A, Koppes W, Miller J, Radman T, O'Neil B, Naunheim R, Huff JS. Classification algorithms for the identification of structural injury in TBI using brain electrical activity. Comput Biol Med. 2014 Oct;53:125-33. doi: 10.1016/j.compbiomed.2014.07.011. Epub 2014 Aug 1.
- Naunheim RS, Treaster M, English J, Casner T. Automated electroencephalogram identifies abnormalities in the ED. Am J Emerg Med. 2011 Oct;29(8):845-8. doi: 10.1016/j.ajem.2010.03.010. Epub 2010 May 1.
- O'Neil B, Prichep LS, Naunheim R, Chabot R. Quantitative brain electrical activity in the initial screening of mild traumatic brain injuries. West J Emerg Med. 2012 Nov;13(5):394-400. doi: 10.5811/westjem.2011.12.6815.
- Naunheim RS, Treaster M, English J, Casner T, Chabot R. Use of brain electrical activity to quantify traumatic brain injury in the emergency department. Brain Inj. 2010;24(11):1324-9. doi: 10.3109/02699052.2010.506862.
- Hanley DF, Chabot R, Mould WA, Morgan T, Naunheim R, Sheth KN, Chiang W, Prichep LS. Use of brain electrical activity for the identification of hematomas in mild traumatic brain injury. J Neurotrauma. 2013 Dec 15;30(24):2051-6. doi: 10.1089/neu.2013.3062. Epub 2013 Nov 23.
- Ayaz SI, Thomas C, Kulek A, Tolomello R, Mika V, Robinson D, Medado P, Pearson C, Prichep LS, O'Neil BJ. Comparison of quantitative EEG to current clinical decision rules for head CT use in acute mild traumatic brain injury in the ED. Am J Emerg Med. 2015 Apr;33(4):493-6. doi: 10.1016/j.ajem.2014.11.015. Epub 2014 Nov 20.
- Prichep LS, Naunheim R, Bazarian J, Mould WA, Hanley D. Identification of hematomas in mild traumatic brain injury using an index of quantitative brain electrical activity. J Neurotrauma. 2015 Jan 1;32(1):17-22. doi: 10.1089/neu.2014.3365.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2015
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. april 2016
Datoer for studieregistrering
Først innsendt
11. februar 2015
Først innsendt som oppfylte QC-kriteriene
19. februar 2015
Først lagt ut (Anslag)
20. februar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. april 2016
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-Ahead
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