Salivary Biomarkers in Pediatric Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02609568|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 14, 2017
|Condition or disease|
|Traumatic Brain Injury|
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.
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 Type :||Observational|
|Actual Enrollment :||77 participants|
|Official Title:||Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury|
|Actual Study Start Date :||April 16, 2014|
|Actual Primary Completion Date :||March 17, 2017|
|Actual Study Completion Date :||March 30, 2017|
Control Group 1
Children with non-trauma complaints
Control Group 2
Children with non TBI and musculoskeletal trauma
Children admitted to hospital with moderate/severe isolatedTBI
- Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE) [ Time Frame: Within 24 hours of injury ]Within 24 hours of an acute isolated TBI
- Glasgow Coma Scale measurement of injury severity [ Time Frame: 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.
- Brain CT Scan abnormalities suggesting significant brain injury [ Time Frame: Within 24 hours of injury ]Dichotomous measure: presence or absence of such abnormalities
- Need for mechanical ventilation [ Time Frame: 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.
- Need for neurosurgical intervention including ICP monitor [ Time Frame: During hospitalization (up to 50 days) ]Dichotomous measure: whether or not neurosurgical intervention is needed
- Patient's Length of Stay or hospitalization [ Time Frame: Duration of hospitalization (up to 50 days) ]Number of days spent in hospital
- Final disposition [ Time Frame: At end of hospitalization (up to 50 days) ]Polytomous measure: Discharge to home, discharge to rehab, or death
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609568
|United States, Arizona|
|Maricopa Integrated Health System|
|Phoenix, Arizona, United States, 85008|
|Study Director:||Claudia Yeung, MD||Valleywise Health|
|Study Director:||Kevin Foster, MD||Valleywise Health|