Assessment of InfraScanner 2000™ in Detecting Subdural an... | NCT03353246

NCT03353246

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

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 CT scans over the course of his or her hospitalization, affording the opportunity to one to numerous measurements from each patient during his or her hospital stay.

Within 30 minutes following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). The procedure will entail placing 8 plastic light guides upon the patient's scalp. The study team member will use the device to sequentially emit light through each of the 8 light guides so that the light is incident upon scalp (Image B). The device is engineered such that the light emitter and receiver are spaced ~4cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting the patient, placing the light guides, gathering the data, and removing the light guides should take ~10 minutes each time. The number of CT scans the patient receives determines the number of potential data collections. The patient will be approached by the study team following each CT scan to be scanned with the InfraScanner 2000™ (20). 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 Research Electronic Data Capture (REDCap) and/or Microsoft Excel 2016 on a secured DHTS server (S:\NSU_IRB\Pro00087011).

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
InfraScanner 2000™	Experimental	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InfraScanner 2000™	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level	Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level	Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level	Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level	Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level	Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level	Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level	Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Michael Haglund, MD, PhD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 7, 2018	May 3, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

InfraScanner 2000™

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units	Counts
Participants	BG000500

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.4± 25.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000211
Male	BG000289

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000104
Not Hispanic or Latino	BG000396

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG00028

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000500

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

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level

Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.

For participants who had more than one scan, the first scan was used.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units	Counts
Participants	OG000500

Title

Denominators

Categories

Title	Measurements
	OG00085.6(78.8 to 92.3)

Primary

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level

Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.

Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

Scans

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units

Primary

Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.

For participants who had more than one scan, the first scan was used.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units	Counts

Primary

Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.

Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

Scans

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units

Primary

False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.

For participants who had more than one scan, the first scan was used.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units	Counts

Primary

False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.

Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

Scans

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Primary

False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.

For participants who had more than one scan, the first scan was used.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Units	Counts

Primary

False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.

Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

Scans

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Secondary

Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level

Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.

For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Secondary

Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level

Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.

For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Secondary

Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level

Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.

Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

Hematomas

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Secondary

False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level

Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.

Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Secondary

Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level

Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.

Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

CT scans

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Secondary

False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level

Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.

Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.

Posted

Number

95% Confidence Interval

percentage

Up to 30 days after first CT scan

CT scans

ID	Title	Description
OG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	InfraScanner 2000™	All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. 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.	0	500	0	500	0	500

ID	Term
D006259	Craniocerebral Trauma
D016489	Head Injuries, Closed
D020197	Head Injuries, Penetrating

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D014949	Wounds, Nonpenetrating
D014950	Wounds, Penetrating