NCT01922531

Brief Summary

To measure Axonal Injury in children with mild traumatic brain injury enrolled in an Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

August 12, 2013

Last Update Submit

August 13, 2013

Conditions

Traumatic Brain Injury

Keywords

mTBIMild Traumatic Brain InjuryAxonal Injury

Outcome Measures

Primary Outcomes (1)

  • Differences in mean FA

    The primary analysis was to test for significant differences in mean Fractional Anisotropy in the Corpus Callosum between the mild traumatic brain injured patients and orthopedic controls.

    72 hours post enrollment

Secondary Outcomes (1)

  • Functional Outcomes following mTBI

    1 week and 1 month post injury

Other Outcomes (1)

  • Biomarkers

    6 hours post injury

Study Arms (2)

Mild Traumatic Brain Injury

These were patients who presented to the ER within 6 hours of a witnessed head injury. Patients were also eligible if the patient had a self-reported head injury with evidence of head trauma.

Orthopedic Injury

Patients were eligible as an orthopedic injured control who presented to the ER within 6 hours of an isolated extremity trauma that radiography and an Abbreviated Injury Scale (AIS) of less than or equal to 3.

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to a Pediatric Emergency Department

You may qualify if:

  • Orthopedic Injury Control Group:

You may not qualify if:

  • Orthopedic Injury Control Group:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Concussion

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Lynn Babcock, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

September 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

US(1)