Clinical trial NCT03062566: Prognostic Potential of Prehospital Biomarkers in TBI Patients
Official title: Prognostic Potential of Prehospital S100B, Glial Fibrillary Acidic Protein (GFAP) and Neuron Specific Annuals (NSE) Levels in Patients Suffering Severe Traumatic Brain Injury (TBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain INjury
Keywords: biomarkers
point-of-care analysis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: Aarhus University Hospital
First posted: 2017-02-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
timeFrame: in relation to event within 1 year
measure: Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
timeFrame: in relation to event within 1 year
measure: 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
timeFrame: in relation to event within 1 year
measure: 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
timeFrame: in relation to event within 1 year
Secondary outcomes:
measure: Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
timeFrame: in relation to event within 1 year
measure: Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
timeFrame: in relation to event within 1 year of trauma
measure: Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
Other outcomes:
measure: Mortality rates corresponding to se-S100B values
timeFrame: in relation to event within 1 year of trauma
measure: Mortality rates corresponding to se-GFAP values
timeFrame: in relation to event within 1 year of trauma
measure: Mortality rates corresponding to se-NSE values
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
measure: 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
timeFrame: in relation to event within 1 year of trauma
Locations:
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Services, Central Denmark Region
Study officials:
References: