InfraScanner 2000 for Traumatic Brain Injury

N/A

Waitlist Available

Led By Shobhan Vachhrajani, MD, PhD

Research Sponsored by Dayton Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

0-18 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a new technology that might help doctors check for head trauma without radiation-emitting CT scans.

Who is the study for?

This trial is for children and teenagers aged 0-18 who are suspected to have a traumatic brain injury (TBI) and are about to get a CT scan. They must be conscious with varying levels of responsiveness, as measured by the Glasgow Coma Score between 3-15. Children who've had recent surgery aren't eligible.

What is being tested?

The study is testing the Infrascanner model 2000, which uses near-infrared spectroscopy (NIRS) technology to detect bleeding in the brain after an injury. It aims to see if NIRS can match or replace CT scans in diagnosing head trauma without exposing young patients to radiation.

What are the potential side effects?

Since NIRS involves scanning with light, it's non-invasive and doesn't have side effects like medical drugs do. However, there might be indirect consequences if it fails to detect actual bleeding that requires immediate attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Predictive Values of NIRS Measurement

Sensitivity of NIRS Optical Density Measurement

Specificity of NIRS Optical Density Measurement

Secondary study objectives

Implementation of NIRS in Emergency Department Workflow

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InfraScanner 2000Experimental Treatment1 Intervention

All participants entered into the study will undergo at least one cranial scanning using the InfraScanner 2000 within 4 hours before or after CT scan. Patients will know the results of the CT scan but not of the InfraScanner 2000. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative.

0 / 1Eligibility criteria met