A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection
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|ClinicalTrials.gov Identifier: NCT00576147|
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : December 20, 2013
Last Update Posted : March 29, 2018
The purposes of this study are:
- To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma.
- To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers
|Condition or disease||Intervention/treatment||Phase|
|TBI (Traumatic Brain Injury)||Device: Infrascanner||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||431 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Experimental: CT scan
The standard head CT done to head trauma patients
The main Near-Infrared spectroscopy (NIRS) head measurement
- 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 ]
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 Reproducibility of the Near-Infrared Spectroscopy (NIRS) Measurements With Different Operators and at Different Centers [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576147
|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|
|Principal Investigator:||Claudia Robertson, MD||Professor Medical Director, The Center for Neurosurgical Intensive Care, Ben Taub Hospital, Houston, Texas|