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Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children

NCT02149082 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 465

Last updated 2018-11-07

No results posted yet for this study

Summary

This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density (OD) measurement with an Infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (CT) scans as the gold standard.

Conditions

  • Intracranial Hematoma

Interventions

DEVICE

Infrascanner Model 2000

The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding.

Sponsors & Collaborators

Principal Investigators

  • Matthew Kirschen, MD, PhD · Children's Hospital of Philadelphia

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02149082 on ClinicalTrials.gov