An observational study in Traumatic Brain INjury, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by University of Aarhus · Observational
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:
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 6 is below the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
GCS 3-8
Other: Blood sampling
Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: in relation to event within 1 year
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: in relation to event within 1 year of trauma
Mortality rates corresponding to se-S100B values
survival versus death \<7 days, 3 months and 6 months after trauma 6-month
Time frame: in relation to event within 1 year of trauma
Mortality rates corresponding to se-GFAP values
survival versus death \<7 days, 3 months and 6 months after trauma 6-month
Time frame: in relation to event within 1 year of trauma
Mortality rates corresponding to se-NSE values
survival versus death \<7 days, 3 months and 6 months after trauma 6-month
Time frame: in relation to event within 1 year of trauma
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
Time frame: in relation to event within 1 year of trauma
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: in relation to event within 1 year of trauma
Plan to share: No
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University of Aarhus