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

Completed · Not applicable

Conditions studied: TBI (Traumatic Brain Injury)

In brief

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

Key facts

Study ID

NCT00576147

Run by

InfraScan, Inc.

People needed

431

Starts

2006-07-01

Expected to finish

2011-01-01

Last updated by the study team

2018-11-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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