Traumatic Brain InjuryNCT02609568
Salivary Biomarkers in Pediatric Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Valleywise Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2014to 30 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 1) 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; 2) pediatric patients who present to the ED with non-trauma complaints; and 3) pediatric patients who present to the ED with non-head trauma such as musculoskeletal injuries.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maricopa Integrated Health System
Phoenix, Arizona, 85008
About this study
Official title: Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Children, Head injury, Salivary biomarker, Trauma Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 | Children with non-trauma complaints | |
| Control Group 2 | Children with non TBI and musculoskeletal trauma | |
| Cases | Children admitted to hospital with moderate/severe isolatedTBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)
Within 24 hours of an acute isolated TBI
Measured: Within 24 hours of injury
Secondary outcomes (6)
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.
Measured: Day 1
Brain CT Scan abnormalities suggesting significant brain injury
Dichotomous measure: presence or absence of such abnormalities
Measured: Within 24 hours of injury
Need for mechanical ventilation
Mechanical ventilators are used for patients who cannot breathe by themselves. Dichotomous measure: whether or not mechanical ventilation is needed.
Measured: During hospitalization (up to 50 days)
Need for neurosurgical intervention including ICP monitor
Dichotomous measure: whether or not neurosurgical intervention is needed
Measured: During hospitalization (up to 50 days)
Patient's Length of Stay or hospitalization
Number of days spent in hospital
Measured: Duration of hospitalization (up to 50 days)
Final disposition
Polytomous measure: Discharge to home, discharge to rehab, or death
Measured: At end of hospitalization (up to 50 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start16 Apr 2014
- Primary completion17 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Yeung, MD, Study director, Valleywise HealthKevin Foster, MD, Study director, Valleywise Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609568
- Sponsor's protocol ID
- 2014-055
- Status last verified
- Sep 2017
- First submitted
- 16 Oct 2014
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23399646Olsson 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.
PubMed 21524681Faul 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02609568
- Acronym / sponsor ID
- 2014-055
- Conditions
- Traumatic Brain Injury
- Keywords
- Children, Head injury, Salivary biomarker, Trauma Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Study start
- 16 Apr 2014 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 | – | –Children with non-trauma complaints |
| Control Group 2 | – | –Children with non TBI and musculoskeletal trauma |
| Cases | – | –Children admitted to hospital with moderate/severe isolatedTBI |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1) 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; 2) pediatric patients who present to the ED with non-trauma complaints; and 3) pediatric patients who present to the ED with non-head trauma such as musculoskeletal injuries.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Glasgow Coma Scale measurement of injury severity
Time frame: Day 1
Brain CT Scan abnormalities suggesting significant brain injury
Time frame: Within 24 hours of injury
Need for mechanical ventilation
Time frame: During hospitalization (up to 50 days)
Need for neurosurgical intervention including ICP monitor
Time frame: During hospitalization (up to 50 days)
Patient's Length of Stay or hospitalization
Time frame: Duration of hospitalization (up to 50 days)
Final disposition
Time frame: At end of hospitalization (up to 50 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Background: PubMed 23399646Zetterberg 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.
- Background: PubMed 21524681Olsson 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.
- BackgroundFaul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Yeung, MD study director
Valleywise Health
Kevin Foster, MD study director
Valleywise Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Valleywise Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE) (time frame: Within 24 hours of injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609568, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.