NCT02609568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

2.9 years

First QC Date

October 16, 2014

Last Update Submit

September 12, 2017

Conditions

Traumatic Brain Injury

Keywords

ChildrenHead injurySalivary biomarkerTrauma Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)

    Within 24 hours of an acute isolated TBI

    Within 24 hours of injury

Secondary Outcomes (6)

  • Glasgow Coma Scale measurement of injury severity

    Day 1

  • Brain CT Scan abnormalities suggesting significant brain injury

    Within 24 hours of injury

  • Need for mechanical ventilation

    During hospitalization (up to 50 days)

  • Need for neurosurgical intervention including ICP monitor

    During hospitalization (up to 50 days)

  • Patient's Length of Stay or hospitalization

    Duration of hospitalization (up to 50 days)

  • +1 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Location

Related Publications (3)

  • 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.

    PMID: 23399646BACKGROUND

  • 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.

    PMID: 21524681BACKGROUND

  • 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.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary biomarkers: S100B, neuron-specific enolase, GFAP

MeSH Terms

Conditions

Brain Injuries, TraumaticCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Claudia Yeung, MD

    Valleywise Health

    STUDY DIRECTOR

  • Kevin Foster, MD

    Valleywise Health

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2014

First Posted

November 20, 2015

Study Start

April 16, 2014

Primary Completion

March 17, 2017

Study Completion

March 30, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)