An interventional study of InfraScanner 2000™ in Head Trauma, Craniocerebral Injuries and Crushing Skull Injury, sponsored by Duke University. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approaching the patient. While head trauma frequently results in impaired cognition and/or consciousness, and due to the urgency of these circumstances patients are often not accompanied by kin, whenever appropriate, the purpose of the research and the procedure will be explained in detail with all questions answered to the patient's and/or representative's satisfaction. Because patients who sustain head trauma injuries typically remain within the hospital for multiple days for monitoring and care, each participant may undergo multiple Computed Tomography (CT) scans over the course of his or her hospitalization, affording the opportunity of one to numerous measurements from each patient during his or her hospital stay.
Upon presentation to the casualty unit at MRRH and following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). If permission is granted, the study team member sequentially measure the optical absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and occipital bilaterally) (Image B). The device is engineered such that the light emitter and receiver are spaced 4 cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting and scanning the patient should take \<10 minutes. Subsequent CT scan(s) the patient receives determines the number of potential data collections.
The patient and/or representative may refuse a scan during any encounter, and as such, the scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be de-identified with a subject number, with age, sex, gender, skin color, hair color, hair thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT scan and near-infrared measurement. These data will be stored in de-identified form on the Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured network drive within the Department of Neurosurgery at Duke.
The collection period for each research subject concludes 30-days following his or her initial measurement with the InfraScanner 2000™, patient discharge, or patient death.
33 studies on the registry are indexed under Head Injuries, Closed; 3 are open to participants now.
This study's enrollment of 672 is above the median of 77 across 25 interventional studies indexed under Head Injuries, Closed.
Browse Head Injuries, Closed studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within Head Injuries, Closed, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Craniocerebral Trauma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
Device: InfraScanner 2000™
The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status
Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma).
Time frame: Within 30 minutes following CT scan
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma)
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume \>3.5 mL) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (\>3.5 ml in volume) or depths (\<2.5 cm from the skull) were used.
Time frame: Within 30 minutes following CT scan
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma)
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (depth \<2.5 cm) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (\>3.5 ml in volume) or depths (\<2.5 cm from the skull) were used.
Time frame: Within 30 minutes following CT scan
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE)
Clinical patient outcomes as measured by the Glasgow Outcomes Scale (GOSE) at discharge. The GOSE is rated from 1 to 8, 1 being death and 8 being upper good recovery.
Time frame: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Identify Reasons CT Not Performed
CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.
Time frame: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Causes of Head Trauma as Identified Through the Medical Record
RTA = Road Traffic Accident
Time frame: Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
Participants were recruited from Mbarara Regional Referral Hospital in Mbarara, Uganda from the casualty ward. Participants were eligible for participation if they had a traumatic brain injury and could complete a CT and infrascan within 30 minutes of each other.
| Milestone | InfraScanner 2000™ |
|---|---|
| Started | 672 |
| Completed | 387 |
| Not completed | 285 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Ct scan unreadable | 277 |
Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma).
| Participants | InfraScanner 2000™ and CT (Computerized Tomography) Scan |
|---|---|
| CT positive — Infrascan positive | 158 |
| CT positive — Infrascan negative | 22 |
| CT negative — Infrascan positive | 126 |
| CT negative — Infrascan negative | 81 |
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume \>3.5 mL) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (\>3.5 ml in volume) or depths (\<2.5 cm from the skull) were used.
| Participants | InfraScanner 2000™ and CT (Computerized Tomography) Scan |
|---|---|
| CT positive (adjusted for volume/size) — InfraScan positive (adjusted for volume/size) | 136 |
| CT positive (adjusted for volume/size) — InfraScan negative (adjusted for volume/size) | 15 |
| CT negative (adjusted for size) — InfraScan positive (adjusted for volume/size) | 126 |
| CT negative (adjusted for size) — InfraScan negative (adjusted for volume/size) | 81 |
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (depth \<2.5 cm) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (\>3.5 ml in volume) or depths (\<2.5 cm from the skull) were used.
| Participants | InfraScanner 2000™ and CT (Computerized Tomography) Scan |
|---|---|
| CT positive (adjusted for depth) — InfraScan positive (adjusted for depth) | 148 |
| CT positive (adjusted for depth) — InfraScan negative (adjusted for depth) | 17 |
| CT negative (adjusted for depth) — InfraScan positive (adjusted for depth) | 126 |
| CT negative (adjusted for depth) — InfraScan negative (adjusted for depth) | 81 |
Clinical patient outcomes as measured by the Glasgow Outcomes Scale (GOSE) at discharge. The GOSE is rated from 1 to 8, 1 being death and 8 being upper good recovery.
| Participants | InfraScanner 2000™ |
|---|---|
| 8 = Upper Good Recovery | 47 |
| 7 = Lower Good Recovery | 252 |
| 6 = Upper Moderate Disability | 41 |
| 5 = Lower Moderate Disability | 9 |
| 4 = Upper Severe Disability | 2 |
| 3 = Lower Severe Disability | 0 |
| 2 = Vegetative State | 0 |
| 1 = Dead | 26 |
CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.
No measurements were reported for this outcome.
RTA = Road Traffic Accident
| Participants | InfraScanner 2000™ |
|---|---|
| RTA - Boda without helmet | 179 |
| RTA - Boda with helmet | 36 |
| RTA - Pedestrian hit by boda | 24 |
| RTA - Pedestrian hit by car or bus | 14 |
| RTA - Car without seatbelt | 12 |
| RTA - Car unknown seatbelt | 9 |
| RTA - Other | 17 |
| RTA - Car with seatbelt | 4 |
| RTA - Boda unknown helmet | 3 |
| Assault | 66 |
| Fall | 11 |
| Other | 6 |
| Accidental Injury | 4 |
| Unknown | 2 |
Collected over Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | 33/672 (4.9%) | — | — |
| Age, Continuous(years) | InfraScanner 2000™ |
|---|---|
| Mean | 32.98 ± 13.25 |
| Sex: Female, Male(Participants) | InfraScanner 2000™ |
|---|---|
| Female | 79 |
| Male | 593 |
| Ethnicity (NIH/OMB)(Participants) | InfraScanner 2000™ |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 672 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | InfraScanner 2000™ |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 672 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | InfraScanner 2000™ |
|---|---|
| Uganda | 672 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2021 to primary completion in Jun 2022, 8 months.
Results were first posted in Mar 2024, 1 year 8 months after primary completion.
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