Salivary Biomarkers in Pediatric Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT02609568
• Lead Sponsor: Valleywise Health

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.

Study Timeline

• Study Start: 2014-04-16
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Primary Completion: 2017-03-17
• Study Completion: 2017-03-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)	Within 24 hours of injury	Within 24 hours of an acute isolated TBI

Secondary Outcome Measures

Name	Time	Method
Patient's Length of Stay or hospitalization	Duration of hospitalization (up to 50 days)	Number of days spent in hospital
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.
Need for neurosurgical intervention including ICP monitor	During hospitalization (up to 50 days)	Dichotomous measure: whether or not neurosurgical intervention is needed
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.
Final disposition	At end of hospitalization (up to 50 days)	Polytomous measure: Discharge to home, discharge to rehab, or death

Trial Locations

Locations (1)

Maricopa Integrated Health System; 🇺🇸 Phoenix, Arizona, United States