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

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576147
• Other study ID #: Infrascanner-052306
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: January 2011

Study information

• Verified date: October 2018
• Source: InfraScan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Undergoing a CT scan within 12 hours of their head injury. The criteria for obtaining a CT scan will be based on the standard of care, but generally all patients with a moderate or severe head injury will receive a CT scan on admission to the hospital, and only patients who undergo a CT will be enrolled into the study. The non-contrast CT will be performed according to standard methods.

Exclusion Criteria:

• 12 hours or more since injury.

• Massive scalp lacerations, avulsions, and hematomas The limitation to injury within 12 hours is necessary because as hematoma blood is metabolized, the absorbance characteristics change.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hematoma
• TBI (Traumatic Brain Injury)

Intervention

Device:
• Infrascanner
The main Near-Infrared spectroscopy (NIRS) head measurement

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
InfraScan, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gopinath SP, Robertson CS, Grossman RG, Chance B. Near-infrared spectroscopic localization of intracranial hematomas. J Neurosurg. 1993 Jul;79(1):43-7. — View Citation

Robertson CS, Gopinath S, Chance B. Use of near infrared spectroscopy to identify traumatic intracranial hemotomas. J Biomed Opt. 1997 Jan;2(1):31-41. — View Citation

Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, Garza H, Maloney-Wilensky E, Plaum JM, Koenig CH, Johnson A, Morgan T. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrau — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma.	We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.; Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements.	2 years