- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03028376
Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients (PreTBI II)
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.
Přehled studie
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Aarhus N, Dánsko, 8200
- Prehospital Emergency Medical Services, Central Denmark Region
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Moderate TBI patients
GCS 9-13
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Odběr krve z periferního žilního katétru běžně zaváděného u pacientů s traumatem během přepravy
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
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
Časové okno: 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
Časové okno: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
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
Časové okno: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
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
Časové okno: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
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
Časové okno: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
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
Časové okno: in relation to event within 7 days of trauma
|
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
Časové okno: 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
Časové okno: in relation to event within 7 days of trauma
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in relation to event within 7 days of trauma
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Dynamika biomarkerů mezi přednemocniční a hospitalizační kombinací hodnot se-S100B, se-GFAP a se-NSE ve vztahu k binárnímu výsledku měřenému otázkou ano/ne „příznivého neurologického výsledku“ vybere příznivé/nepříznivé
Časové okno: ve vztahu k události do 1 roku od traumatu
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ve vztahu k události do 1 roku od traumatu
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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
Časové okno: 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
Časové okno: in relation to event within 24 hours of trauma
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in relation to event within 24 hours of trauma
|
|
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
Časové okno: in relation to event within 24 hours of trauma
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in relation to event within 24 hours of trauma
|
|
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
Časové okno: 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-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
Časové okno: 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
Časové okno: 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-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Časové okno: 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
Časové okno: 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)
|
in relation to event within 1 year of trauma
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Protokol_v3_240816_PreTBI_II
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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