Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients (PreTBI II)
23 april 2019 uppdaterad 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.
Studieöversikt
Studietyp
Observationell
Inskrivning (Faktisk)
22
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Aarhus N, Danmark, 8200
- Prehospital Emergency Medical Services, Central Denmark Region
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 100 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Moderate TBI patients
GCS 9-13
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Blodprovtagning från perifer venkateter som rutinmässigt sätts in i traumapatienter under transport
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: 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
Tidsram: 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-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Biomarkörsdynamik mellan prehospital och in-hospital kombination av se-S100B, se-GFAP och se-NSE värden i relation till ett binärt utfall mätt med en ja/nej fråga om "gynnsamt neurologiskt utfall" välj gynnsamt/ogynnsamt
Tidsram: i förhållande till händelse inom 1 år efter trauma
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i förhållande till händelse inom 1 år efter trauma
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 februari 2017
Primärt slutförande (Faktisk)
1 februari 2019
Avslutad studie (Faktisk)
1 februari 2019
Studieregistreringsdatum
Först inskickad
21 november 2016
Först inskickad som uppfyllde QC-kriterierna
19 januari 2017
Första postat (Uppskatta)
23 januari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2019
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Protokol_v3_240816_PreTBI_II
Plan för individuella deltagardata (IPD)
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NEJ
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