S100 Protein in Minor/Mild Traumatic Brain Injury
Condition: Minor/Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events
      (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used
      for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this
      imagery are critical factors. We hypothesized that the blood level measurement of S100
      protein (S100), a neurological biomarker of cerebral injury, would help to the clinical
      evaluation of minor/mild head injury events, and would be an economic alternative to CCT for
      the diagnosis of these pathologies. In addition, a part of the study will explore the
      prognostic value of such blood level S100 determination for the evaluation of medical/social
      consequences of minor/mild TBI.

      Medical objective of the study:

        1. to assess the contribution of early determination (to medical care) of S100 for the
           diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),

        2. to determine the usefulness of a second dosage three hours later for the medical
           decision.

      In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold
      Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use.

      Economic objective:

      to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the
      diagnosis of minor/moderate TBI and its medical/social consequences
    

Detailed description: 
      Nearly two hundred thousand head injury cases (Traumatic Brain Injury - TBI) are reported
      each year in France. Less than 5% are severe, defined by a Glasgow score (GCS) above 9.
      Epidemiological studies indicate that TBI is the fourth leading cause of death and disability
      in industrialized countries. Major causes of mild/minor TBI are falls and domestic trauma in
      the elderly or children, and sports accidents. The minor/mild brai injury (MBI) may represent
      5 to 10% of emergency consultations in the UAA.

      The severity of a head injury is assessed by the Glasgow Coma Scale (GCS), and TBI are
      divided into three groups: minor (13-15), moderate (9-12) , severe (3-8). Definition of TCC
      has considerably evolved over the past 20 years, to take into account the pathophysiologic
      lesions secondary is related to systemic factors (hypotension, hypoxia ...) and intracranial
      factors ( intracranial hypertension, seizures committals ...). These side events, occurring
      within hours or days after the primary injury caused by an impact (contusion, hematoma,
      deceleration), increase the morbidity of the initial event, and must therefore be detected
      both early and fully.

      The diagnosis of TBI requires imaging data such as craniocerebral tomography (CCT), which
      will be renewed after 24 hours and if necessary the following day. Until now, no pertinent
      biological marker was proposed to complete the clinical/imagery investigation of
      mild/moderate TBI.

      S100B protein (S100) is a constitutive protein of glial cells, whose physiological functions
      are both intracellular, i.e. intracytosolic calcium binding, and extracellular, e.g. by
      promoting neuritic proliferation and/or neuronal apoptosis. Due to specificity of its
      cellular expression, S100B protein is a useful biological marker of acute neurological
      disorders, such as ischemic or haemorrhagic stroke, and traumatic head injury. hemorrhage,
      ischemic stroke) or traumatic (TCC). Plasma S100 is significantly increased in subjects with
      a major TCC, but also in the majority of minor or moderate TBI. A prognostic value of S100
      also was suggested : patients who exhibited medical or social sequelae after several months
      after TBI also shoed high plasma levels of S100 in the first hours of the head injury. Such
      results of international clinical studies proposed S100 as a biomarker of diffuse brain
      injury, and indicate the importance of early determination of plasma concentration of S100
      and its integration among the other elements of diagnosis (imaging) for assessing the
      severity of trauma and its short and long terms.

      Medical objective of the study:

        1. to assess the contribution of early determination (to medical care) of S100 for the
           diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),

        2. to determine the usefulness of a second dosage three hours later for the medical
           decision.

      In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold
      Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use.

      Economic objective:

      to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the
      diagnosis of minor/moderate TBI and its medical/social consequences.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Minor/mild traumatic brain injury
      
Keywords: Biomarker; S100 protein; Traumatic brain injury; Craniocerebral tomodensitometry; Neurological sequelae