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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InfraScan, Inc.
ClinicalTrials.gov Identifier:
NCT00576147
First received: December 14, 2007
Last updated: December 19, 2013
Last verified: December 2013

December 14, 2007
December 19, 2013
July 2006
January 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

To determine the sensitivity and specificity of the NIRS measurements for identifying intracranial hematomas due to trauma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00576147 on ClinicalTrials.gov Archive Site
To Determine the Reproducibility of the Near-Infrared Spectroscopy (NIRS) Measurements With Different Operators and at Different Centers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the reproducibility of the NIRS measurements with different operators and at different centers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection
A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
TBI (Traumatic Brain Injury)
Device: Infrascanner
The main Near-Infrared spectroscopy (NIRS) head measurement
Active Comparator: Infrascanner measurment and CT scan
The standard head CT done to head trauma patients
Intervention: Device: Infrascanner

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
431
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576147
Infrascanner-052306
No
InfraScan, Inc.
InfraScan, Inc.
Not Provided
Principal Investigator: Claudia Robertson, MD Professor Medical Director, The Center for Neurosurgical Intensive Care, Ben Taub Hospital, Houston, Texas
InfraScan, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP