Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients (PreTBI II)
23. april 2019 oppdatert av: University of Aarhus
S100B and Glial Fibrillary Acidic Protein (GFAP) in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in Patients Suffering Moderate Traumatic Brain Injury (TBI)
The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma.
Hypotheses:
- A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients.
- A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients.
- Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention.
- Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
22
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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Aarhus N, Danmark, 8200
- Prehospital Emergency Medical Services, Central Denmark Region
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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 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance or anaesthetist-staffed critical care team dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.
Beskrivelse
Inclusion Criteria:
- Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.
Exclusion Criteria:
- Patients <18 years, GCS <9, >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Moderate TBI patients
GCS 9-13
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Blodprøvetaking fra perifert venekateter som rutinemessig settes inn i traumepasienter under transport
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
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Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
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Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
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Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
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Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
|
|
Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Biomarkørdynamikk mellom prehospital og sykehusinnlagt kombinasjon av se-S100B, se-GFAP og se-NSE verdier i forhold til et binært utfall målt ved et ja/nei spørsmål om "gunstig nevrologisk utfall" velger gunstig/ugunstig
Tidsramme: i forhold til hendelse innen 1 år etter traume
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i forhold til hendelse innen 1 år etter traume
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Sensitivity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
Tidsramme: in relation to event within 24 hours of trauma
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in relation to event within 24 hours of trauma
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Specificity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
Tidsramme: in relation to event within 24 hours of trauma
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in relation to event within 24 hours of trauma
|
|
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Positive predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
Tidsramme: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
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Negative predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
Tidsramme: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
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Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsramme: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
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Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Tidsramme: in relation to event within 1 year of trauma
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Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
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in relation to event within 1 year of trauma
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Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Tidsramme: in relation to event within 1 year of trauma
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Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
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in relation to event within 1 year of trauma
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
15. februar 2017
Primær fullføring (Faktiske)
1. februar 2019
Studiet fullført (Faktiske)
1. februar 2019
Datoer for studieregistrering
Først innsendt
21. november 2016
Først innsendt som oppfylte QC-kriteriene
19. januar 2017
Først lagt ut (Anslag)
23. januar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2019
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Protokol_v3_240816_PreTBI_II
Plan for individuelle deltakerdata (IPD)
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NEI
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