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

This study has been completed.
Sponsor:
Information provided by:
InfraScan, Inc.
ClinicalTrials.gov Identifier:
NCT00576147
First received: December 14, 2007
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

The purposes of this study are:

  1. To determine the sensitivity and specificity of the NIRS measurements for identifying intracranial hematomas due to trauma.
  2. To determine the reproducibility of the 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: Factorial 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:

U.S. FDA Resources

Further study details as provided by InfraScan, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine the reproducibility of the 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: CT Scan
The standard head CT done to head trauma patients
 Device: Infrascanner
The main NIRS head measurement

  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
Hahnemann Hospital
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
InfraScan, Inc.
  More Information

Publications:
C. S. Robertson, S. P. Gopinath, and B. Chance. Use of near infrared spectroscopy to identify traumatic intracranial hematomas. J. Biomed. Opt. 2, 31-41 (1997).

Responsible Party: Baruh Ben Dor, CEO, InfraScan
ClinicalTrials.gov Identifier: NCT00576147     History of Changes
Other Study ID Numbers: Infrascanner-052306
Study First Received: December 14, 2007
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by InfraScan, Inc.:
TBI
NIRS
Hematoma

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

ClinicalTrials.gov processed this record on May 23, 2013