An interventional study of Infrascanner in TBI (Traumatic Brain Injury), sponsored by InfraScan, Inc.. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by InfraScan, Inc. · Not applicable, Interventional, and Diagnostic
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 431 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →InfraScan, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The standard head CT done to head trauma patients
Device: Infrascanner
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.
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
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
| Milestone | CT Scan |
|---|---|
| Started | 431 |
| Completed | 431 |
| Not completed | 0 |
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.
| Number of participants | CT Scan |
|---|---|
| True Positive | 44 (74.9 to 95.0) |
| False Positive | 25 |
| True Negatives | 244 |
| False Negatives | 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT Scan | — | 0/431 (0%) | 0/431 (0%) |
| Age, Categorical(Participants) | CT Scan |
|---|---|
| <=18 years | 46 |
| Between 18 and 65 years | 333 |
| >=65 years | 52 |
| Age, Continuous(years) | CT Scan |
|---|---|
| Mean | 36.7 ± 26 |
| Sex: Female, Male(Participants) | CT Scan |
|---|---|
| Female | 108 |
| Male | 323 |
| Region of Enrollment(participants) | CT Scan |
|---|---|
| United States | 306 |
| India | 125 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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