Maricopa Integrated Health System
Phoenix, Arizona, 85008, United States
NCT Number: NCT02609568
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.
Looking for future studies?
Notify MeUp to 18 year
All sexes
Observational
Phoenix, Arizona, 85008, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 24 hours of injury
Within 24 hours of an acute isolated TBI
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.
Time frame: Within 24 hours of injury
Dichotomous measure: presence or absence of such abnormalities
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.
Time frame: During hospitalization (up to 50 days)
Dichotomous measure: whether or not neurosurgical intervention is needed
Time frame: Duration of hospitalization (up to 50 days)
Number of days spent in hospital
Time frame: At end of hospitalization (up to 50 days)
Polytomous measure: Discharge to home, discharge to rehab, or death
Valleywise Health
Other
Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01633268
Brain Diseases, Brain Injuries
Bethesda, Maryland, United States
View Trial DetailsNCT03539848
Brain Concussion, Brain Diseases
Miami, Florida, United States
View Trial DetailsNCT05629169
Brain Concussion, Brain Diseases
New York, United States
View Trial DetailsNCT02061553
Anxiety Disorders, Behavior
Elkins Park, Pennsylvania, United States
View Trial Details