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S100B and Glial Fibrillary Acidic Protein (GFAP) in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in Patients Suffering Moderate Traumatic Brain Injury (TBI) (NCT03028376)

Aarhus University Hospital
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 > 10 microgram g/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.
  • Other: Blood sampling
    Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
    Ages eligible for Study
    18 Years to 100 Years
    Genders eligible for Study
    All
    Accepts 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.

    1 locations

    Denmark (1)
    • Prehospital Emergency Medical Services, Central Denmark Region
      recruiting
      Aarhus N, Denmark, 8200
    Status:
    recruiting
    Type:
    Observational
    Phase:
    -
    Start:
    14 February, 2017
    Updated:
    19 February, 2017
    Participants:
    100
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