TBI (Traumatic Brain Injury)
Conditions
Keywords
TBI, NIRS, Hematoma
Brief summary
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
Detailed description
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.
Interventions
DEVICEInfrascanner
The main Near-Infrared spectroscopy (NIRS) head measurement
Sponsors
InfraScan, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| CT Scan The standard head CT done to head trauma patients | 431 |
| Total | 431 |
Baseline characteristics
| Characteristic | CT Scan |
|---|---|
| Age, Categorical <=18 years | 46 Participants |
| Age, Categorical >=65 years | 52 Participants |
| Age, Categorical Between 18 and 65 years | 333 Participants |
| Age, Continuous | 36.7 years STANDARD_DEVIATION 26 |
| Region of Enrollment India | 125 participants |
| Region of Enrollment United States | 306 participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 323 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 431 |
| serious Total, serious adverse events | 0 / 431 |
Outcome results
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CT Scan | 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. | True Positive | 44 Number of participants |
| CT Scan | 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. | False Positive | 25 Number of participants |
| CT Scan | 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. | True Negatives | 244 Number of participants |
| CT Scan | 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. | False Negatives | 6 Number of participants |
95% CI: [75, 95]
95% CI: [86.4, 93.7]