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The purposes of this study are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT scan | Experimental | The standard head CT done to head trauma patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrascanner | Device | The main Near-Infrared spectroscopy (NIRS) head measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Robertson, MD | Professor Medical Director, The Center for Neurosurgical Intensive Care, Ben Taub Hospital, Houston, Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21231 | United States | ||
| University of Cincinnati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23014820 | Background | Robertson CS, Gopinath S, Chance B. Use of near infrared spectroscopy to identify traumatic intracranial hemotomas. J Biomed Opt. 1997 Jan;2(1):31-41. doi: 10.1117/12.261680. No abstract available. | |
| 8315468 | Background | Gopinath SP, Robertson CS, Grossman RG, Chance B. Near-infrared spectroscopic localization of intracranial hematomas. J Neurosurg. 1993 Jul;79(1):43-7. doi: 10.3171/jns.1993.79.1.0043. |
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Near-Infrared examinations performed on all patients within 30 minutes before the CT scan of the head and within 12 hours of their head injury
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| ID | Title | Description |
|---|---|---|
| FG000 | CT Scan | The standard head CT done to head trauma patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT Scan | The standard head CT done to head trauma patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | 431 Total patients enrolled; 365 total patients evaluated after 66 excluded for protocol violations; 269 Number of patients with no Intracranial Hemorrhage; 96 Number of patients with confirmed intrcranial hemorrhage; 50 Number of patients with Intracranial hemorrhage within detection limits of the device. | Posted | Number | Number of participants | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT Scan | The standard head CT done to head trauma patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Robertson | Baylor College of Medicine | (713) 798-8932 | claudiar@bcm.edu |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Cincinnati |
| Ohio |
| 45267 |
| United States |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| 20568959 | Result | Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, Garza H, Maloney-Wilensky E, Plaum JM, Koenig CH, Johnson A, Morgan T. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010 Sep;27(9):1597-604. doi: 10.1089/neu.2010.1340. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The standard head CT done to head trauma patients |
|
|
|
| 0 |
| 431 |
| 0 |
| 431 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |