Traumatic Brain INjury
Conditions
Keywords
biomarkers, point-of-care analysis
Brief summary
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: 1. 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. 2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients. 3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients. 4. 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. 5. 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.
Interventions
OTHERBlood sampling
Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
Sponsors
Central Denmark Region
Aarhus University Hospital
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
| 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 | in relation to event within 1 year | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
| 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 | in relation to event within 1 year | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
| Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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) |
| Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
| Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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) |
| 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 | 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) |
| 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 | 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) |
| Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | 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) |
| 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 | 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) |
| 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 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year of trauma | — |
| Mortality rates corresponding to se-NSE values | in relation to event within 1 year of trauma | survival versus death \<7 days, 3 months and 6 months after trauma 6-month |
| Mortality rates corresponding to se-GFAP values | in relation to event within 1 year of trauma | survival versus death \<7 days, 3 months and 6 months after trauma 6-month |
| Specificity of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year of trauma | — |
| Positive predictive value of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year of trauma | — |
| Negative predictive value of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year 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 | 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 | in relation to event within 1 year of trauma | — |
| Biomarker dynamics between prehospital and in-hospital se-NSE values in relation to a binary outcome measured by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year of trauma | — |
| Biomarker dynamics between prehospital and in-hospital combination of se-S100B, se-GFAP and se-NSE values in relation to a binary outcome measured by a yes/no question of favorable neurological outcome pick favorable/unfavorable | in relation to event within 1 year of trauma | — |
| Mortality rates corresponding to se-S100B values | in relation to event within 1 year of trauma | survival versus death \<7 days, 3 months and 6 months after trauma 6-month |
Countries
Denmark
Outcome results
None listed