Traumatic Brain INjury
Conditions
Keywords
biomarker, point-of-care analysis
Brief summary
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: 1. 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. 2. 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. 3. 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. 4. 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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | in relation to event within 7 days of trauma |
| 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 | 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 | 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 | in relation to event within 7 days of trauma |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 | 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 | in relation to event within 7 days of trauma |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | in relation to event within 24 hours 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 | — |
| 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
Countries
Denmark
Outcome results
None listed