- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Aarhus N, Danimarca, 8200
- Prehospital Emergency Medical Services, Central Denmark Region
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Moderate TBI patients
GCS 9-13
|
Prelievo di sangue da catetere venoso periferico inserito di routine in pazienti traumatizzati durante il trasporto
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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
Lasso di tempo: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Dinamica dei biomarcatori tra la combinazione preospedaliera e intraospedaliera dei valori di se-S100B, se-GFAP e se-NSE in relazione a un risultato binario misurato da una domanda sì/no di "esito neurologico favorevole" scegliere favorevole/sfavorevole
Lasso di tempo: in relazione all'evento entro 1 anno dal trauma
|
in relazione all'evento entro 1 anno dal trauma
|
|
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
Lasso di tempo: in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
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
Lasso di tempo: in relation to event within 24 hours of trauma
|
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
Lasso di tempo: in relation to event within 24 hours of trauma
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: in relation to event within 1 year of trauma
|
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
|
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
Lasso di tempo: in relation to event within 1 year of trauma
|
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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Protokol_v3_240816_PreTBI_II
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Trauma cranico
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaReclutamentoAnestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaCompletato
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletatoLidocaina | Anestesia Brain MonitoringItalia
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
Hospital Universitari Son DuretaEspen; This research prize was funded by Nestle Nutrition Institute and by Fresenius...CompletatoTrauma da moderato a grave, come definito da an | Injury Severity Score (ISS) > 12 punti sono stati inclusi nello studio.Spagna
-
Assiut UniversityCompletatoMorfometria basata su Brain Voxel in ManiaEgitto
Prove cliniche su Prelievo di sangue
-
Haydarpasa Numune Training and Research HospitalCompletatoDisturbo della coagulazioneTacchino
-
Cerus CorporationReclutamento
-
University Hospital, RouenNon ancora reclutamentoEpatite B | Epatite C | AIDSFrancia
-
MicroPhage, Inc.CompletatoSepsi | Batteriemia | Infezione | Infezione da stafilococcoStati Uniti
-
University Hospital TuebingenReclutamentoPredisposizione genetica alla malattia | Malattie RareGermania
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National... e altri collaboratoriCompletato
-
Cerus CorporationTerminatoMalattia acuta da virus EbolaStati Uniti
-
University of the Balearic IslandsCompletatoPressione sanguigna | Allenamento di resistenzaSpagna
-
Universidade Federal do CearáNon ancora reclutamento
-
Centre Hospitalier Princesse GraceCompletato