Minor/Mild Traumatic Brain Injury Clinical Trial
Official title:
Diagnostic Value and Prognostic Value of the Blood Level Determination of S100 Protein in Minor or Mild Traumatic Brain Injury (GCS Glasgow Score 9 to 15).
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
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.
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Observational Model: Cohort, Time Perspective: Cross-Sectional