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

This study is enrolling participants by invitation only.

First Received: December 14, 2007 Last Updated: December 17, 2007 History of Changes

Sponsored by:	InfraScan, Inc.
Information provided by:	InfraScan, Inc.
ClinicalTrials.gov Identifier:	NCT00576147

Purpose

The purposes of this study are:

To determine the sensitivity and specificity of the NIRS measurements for identifying intracranial hematomas due to trauma.
To determine the reproducibility of the NIRS measurements with different operators and at different centers

Condition	Intervention
TBI (Traumatic Brain Injury)	Device: Infrascanner

MedlinePlus related topics: Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Double Blind (Caregiver, Investigator), Factorial Assignment, Efficacy Study
Official Title:	A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

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 ]

Estimated Enrollment:	300
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2008

Arms	Assigned Interventions
CT Scan: Active Comparator 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).

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

Responsible Party:	InfraScan ( Baruh Ben Dor, CEO )
Study ID Numbers:	Infrascanner-052306
Study First Received:	December 14, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00576147 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by InfraScan, Inc.:

TBI
NIRS
Hematoma

Study placed in the following topic categories:

Craniocerebral Trauma
Hematoma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Hemorrhage
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Hematoma
Pathologic Processes
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Hemorrhage
Brain Injuries

ClinicalTrials.gov processed this record on May 07, 2009