Traumatic Brain Injury
Conditions
Keywords
Children, Head injury, Salivary biomarker, Trauma Brain Injury
Brief summary
By studying individual biomarkers in body fluids such as saliva, there is a potential for detecting injury to the brain resulting from an acute traumatic even that may not be detectable by conventional neuroimaging like CT scans.
Detailed description
Although identification of biomarkers following TBI is a rather novel area of research, few studies that have been done in patients with severe TBI and biomarkers from serum and cerebrospinal fluid have shown to have prognostic significance. However there are no prior studies looking at biomarkers in salivary specimens. In this study we will include patients with moderate and severe TBI who require inpatient admission, and will study 3 specific salivary biomarkers. This is a unique project, since salivary specimen collection is easy and non-invasive and can be collected at any site even on a sports field by using a simple absorbable swab resembling a cigarette stub, unlike blood or CSF that can be highly invasive. Salivary specimens can also be frozen and stored for long periods of time prior to testing. If our study detects abnormalities in levels of these biomarkers when compared to healthy controls, and children with extra-cerebral injuries, in future studies we can look at children and adolescents with minor head traumas and concussions who are discharged from the emergency department after evaluation, and study their long-term outcomes and correlation with salivary biomarkers. Specific aims: To study levels of three specific biomarkers in salivary specimens (GFAP, S100B and NSE) in children with moderate TBI (GCS: 9-12) and severe TBI (GCS: \<8) admitted to a pediatric trauma referral center. These biomarkers have been shown to have prognostic significance in prior studies using serum and CSF.
Interventions
None listed
Sponsors
Valleywise Health
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 0 to 20 who present to the pediatric ED or trauma bay with an isolated acute head injury (moderate or severe) and are admitted for inpatient management; * Pediatric patients who present to the ED with non-trauma complaints; and * Pediatric patients who present to the ED with non-head trauma such as musculoskeletal injuries.
Exclusion criteria
* Patients with multisystem trauma; * Patients with minor head trauma (GCS 13-15) discharged from the pediatric ED * Patients with other pre-existing neurological conditions (such as cerebral palsy, chronic seizure disorder, VP shunts); * Patients with a history suggestive of head trauma from chronic abuse; * Incarcerated patients or patients from juvenile detention facilities; * Refusal of parent/patient to participate for any specific reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE) | Within 24 hours of injury | Within 24 hours of an acute isolated TBI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain CT Scan abnormalities suggesting significant brain injury | Within 24 hours of injury | Dichotomous measure: presence or absence of such abnormalities |
| Need for mechanical ventilation | During hospitalization (up to 50 days) | Mechanical ventilators are used for patients who cannot breathe by themselves. Dichotomous measure: whether or not mechanical ventilation is needed. |
| Glasgow Coma Scale measurement of injury severity | Day 1 | Glasgow Coma Scale is a score between 3 and 15, 3 being the worst, and 15 the best. It is composed of three parameters: Best Eye Response, Best Verbal Response, and Best Motor Response. A Coma Score of 13 or higher correlates with a mild brain injury, 9 to 12 is a moderate injury and 8 or less a severe brain injury. |
| Patient's Length of Stay or hospitalization | Duration of hospitalization (up to 50 days) | Number of days spent in hospital |
| Final disposition | At end of hospitalization (up to 50 days) | Polytomous measure: Discharge to home, discharge to rehab, or death |
| Need for neurosurgical intervention including ICP monitor | During hospitalization (up to 50 days) | Dichotomous measure: whether or not neurosurgical intervention is needed |
Countries
United States
Outcome results
None listed