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Defining the Operating Characteristics of NIRS in the Diagnosis of Pediatric Traumatic Intracranial Hemorrhage

NCT03905031 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-03-06

No results posted yet for this study

Summary

In this study, investigators look at a different type of technology that might help to avoid having to perform CT scans in certain patients suspected of having a head injury. Near-infrared spectroscopy (NIRS) uses a specific light wavelength to determine if there is bleeding into the head as a result of trauma. Investigators will study NIRS, using a device called the Infrascanner model 2000, to determine if it is as good at detecting bleeding in the head as CT scan, which is the current gold standard. Investigators will try to determine if NIRS can rule in or rule out bleeding into the head, and perhaps this can help to avoid subjecting these youth to the potentially harmful effects of radiation. Investigators will also study how easy it is to use NIRS so that it might become a standard part of the workup for children with suspected head injury.

Conditions

  • Craniocerebral Injuries
  • Head Injuries
  • Head Injury, Minor
  • Head Trauma
  • Traumatic Brain Injury
  • Traumatic Brain Hemorrhage
  • Hematoma of Head
  • Intracranial Hemorrhages

Interventions

DEVICE

InfraScanner 2000

The InfraScanner is a portable screening device that measures lateralized differences in optical density (OD) to determine the presence of intracranial hematoma. A difference in OD\>0.2 is abnormal and suggestive of intracranial hematoma.

Sponsors & Collaborators

  • Dayton Children's Hospital

    lead OTHER

Principal Investigators

  • Shobhan Vachhrajani, MD, PhD · Dayton Children's Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03905031 on ClinicalTrials.gov