Salivary Biomarkers in Pediatric Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609568
• Other study ID #: 2014-055
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: September 12, 2017
• Start date: April 16, 2014
• Est. completion date: March 30, 2017

Study information

• Verified date: September 2017
• Source: Maricopa Integrated Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 30, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Maricopa Integrated Health System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Maricopa Integrated Health System

Country where clinical trial is conducted

United States, 

References & Publications (3)

Faul M, Xu L, Wald MM, Coronado V. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002--2006. Atlanta, GA: CDC, National Center for Injury Prevention and Control; 2010.

Olsson B, Zetterberg H, Hampel H, Blennow K. Biomarker-based dissection of neurodegenerative diseases. Prog Neurobiol. 2011 Dec;95(4):520-34. doi: 10.1016/j.pneurobio.2011.04.006. Epub 2011 Apr 16. Review. — View Citation

Zetterberg H, Smith DH, Blennow K. Biomarkers of mild traumatic brain injury in cerebrospinal fluid and blood. Nat Rev Neurol. 2013 Apr;9(4):201-10. doi: 10.1038/nrneurol.2013.9. Epub 2013 Feb 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)	Within 24 hours of an acute isolated TBI	Within 24 hours of injury
Secondary	Glasgow Coma Scale measurement of injury severity	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.	Day 1
Secondary	Brain CT Scan abnormalities suggesting significant brain injury	Dichotomous measure: presence or absence of such abnormalities	Within 24 hours of injury
Secondary	Need for mechanical ventilation	Mechanical ventilators are used for patients who cannot breathe by themselves. Dichotomous measure: whether or not mechanical ventilation is needed.	During hospitalization (up to 50 days)
Secondary	Need for neurosurgical intervention including ICP monitor	Dichotomous measure: whether or not neurosurgical intervention is needed	During hospitalization (up to 50 days)
Secondary	Patient's Length of Stay or hospitalization	Number of days spent in hospital	Duration of hospitalization (up to 50 days)
Secondary	Final disposition	Polytomous measure: Discharge to home, discharge to rehab, or death	At end of hospitalization (up to 50 days)