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
  Purpose

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

Condition Intervention
TBI (Traumatic Brain Injury)
Device: Infrascanner

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

Resource links provided by NLM:


Further study details as provided by InfraScan, Inc.:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Enrollment: 431
Study Start Date: July 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Infrascanner measurment and CT scan
The standard head CT done to head trauma patients
Device: Infrascanner
The main Near-Infrared spectroscopy (NIRS) head measurement

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576147

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
InfraScan, Inc.
Investigators
Principal Investigator: Claudia Robertson, MD Professor Medical Director, The Center for Neurosurgical Intensive Care, Ben Taub Hospital, Houston, Texas
  More Information

Publications:
Responsible Party: InfraScan, Inc.
ClinicalTrials.gov Identifier: NCT00576147     History of Changes
Other Study ID Numbers: Infrascanner-052306
Study First Received: December 14, 2007
Results First Received: April 11, 2012
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by InfraScan, Inc.:
TBI
NIRS
Hematoma

Additional relevant MeSH terms:
Hematoma
Brain Injuries
Wounds and Injuries
Hemorrhage
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014