Prognostic Potential of Prehospital Biomarkers in TBI Patients

Study Overview
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Brief Summary
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The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as predictors of neurological outcome and mortality may underline the potential of a point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the clinical decision-making regarding treatment and level of care offered to the patient. Hypotheses: Prehospital S100B level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E) measures) in severe TBI patients. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients. Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.

Official Title
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Prognostic Potential of Prehospital S100B, Glial Fibrillary Acidic Protein (GFAP) and Neuron Specific Annuals (NSE) Levels in Patients Suffering Severe Traumatic Brain Injury (TBI)

Conditions
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Traumatic Brain INjury

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with Glasgow Coma Score (GCS) GCS 3-8 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: >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe TBI patients<br>GCS 3-8 | Other: Blood sampling<br>* Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Positive predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Negative predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Positive predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Negative predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Positive predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 
| Negative predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarkers, point-of-care analysis