NCT00576147

A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: InfraScan, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purposes of this study are: 1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma. 2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers

Detailed description

The principle used in identifying intracranial hematomas with Near-infrared spectroscopy (NIRS) is that extravascular blood absorbs Near-infrared light more than intravascular blood since there is a greater (usually 10-fold greater) concentration of hemoglobin in the acute hematoma then in the brain tissue where blood is contained within vessels. Therefore, the absorbance of Near-infrared light is greater (and therefore the reflected light less) on the side of the brain containing a hematoma, than on the uninjured side. The NIRS sensor is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at selected wavelengths is recorded. The difference in optical density in the different areas is calculated.

Conditions

• TBI (Traumatic Brain Injury)

Interventions

Type	Name	Description
DEVICE	Infrascanner	The main Near-Infrared spectroscopy (NIRS) head measurement

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-12-18
• Last updated: 2018-11-07
• Results posted: 2013-12-20

Locations

4 sites across 1 country: United States