Trial Outcomes & Findings for Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas (NCT NCT04505293)

Last Updated: 2024-03-19

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

672 participants

Primary outcome timeframe

Within 30 minutes following CT scan

Results posted on

2024-03-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	InfraScanner 2000™ 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. 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.
Overall Study STARTED	672
Overall Study COMPLETED	387
Overall Study NOT COMPLETED	285

Reasons for withdrawal

Reasons for withdrawal
Measure	InfraScanner 2000™ 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. 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.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	6
Overall Study CT scan unreadable	277

Baseline Characteristics

Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InfraScanner 2000™ n=672 Participants 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. 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.
Age, Continuous	32.98 years STANDARD_DEVIATION 13.25 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	593 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	672 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	672 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Uganda	672 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes following CT scan

Population: 180 participants had a positive CT scan; 207 participants had a negative CT scan. One CT per participant.

Outcome measures

Outcome measures
Measure	InfraScanner 2000™ and CT (Computerized Tomography) Scan n=387 Participants 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. 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 CT positive · Infrascan positive	158 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status CT positive · Infrascan negative	22 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status CT negative · Infrascan positive	126 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status CT negative · Infrascan negative	81 Participants

SECONDARY outcome

Timeframe: Within 30 minutes following CT scan

Population: Participants with hematomas within the InfraScanner's detection limits (as determined by CT scan). 151 participants had a positive CT scan and 207 participants had a negative CT scan when adjusted for hematoma volume/size. One CT per participant.

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.

Outcome measures

Outcome measures
Measure	InfraScanner 2000™ and CT (Computerized Tomography) Scan n=358 Participants 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. 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 (Adjusted for Volume and Size of Hematoma) CT positive (adjusted for volume/size) · InfraScan positive (adjusted for volume/size)	136 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) CT negative (adjusted for size) · InfraScan positive (adjusted for volume/size)	126 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) CT positive (adjusted for volume/size) · InfraScan negative (adjusted for volume/size)	15 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) CT negative (adjusted for size) · InfraScan negative (adjusted for volume/size)	81 Participants

SECONDARY outcome

Timeframe: Within 30 minutes following CT scan

Population: Participants with hematomas within the InfraScanner's detection limits (as determined by CT scan). 165 participants had a positive CT scan and 207 participants had a negative CT scan when adjusted for hematoma depth. One CT per participant.

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.

Outcome measures

Outcome measures
Measure	InfraScanner 2000™ and CT (Computerized Tomography) Scan n=372 Participants 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. 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 (Adjusted for Depth of Hematoma) CT positive (adjusted for depth) · InfraScan positive (adjusted for depth)	148 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) CT positive (adjusted for depth) · InfraScan negative (adjusted for depth)	17 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) CT negative (adjusted for depth) · InfraScan positive (adjusted for depth)	126 Participants
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) CT negative (adjusted for depth) · InfraScan negative (adjusted for depth)	81 Participants

SECONDARY outcome

Timeframe: 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.

Population: Data not collected on 10 participants.

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.

Outcome measures

Outcome measures
Measure	InfraScanner 2000™ and CT (Computerized Tomography) Scan n=377 Participants 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. 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.
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 8 = Upper Good Recovery	47 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 7 = Lower Good Recovery	252 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 6 = Upper Moderate Disability	41 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 5 = Lower Moderate Disability	9 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 4 = Upper Severe Disability	2 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 3 = Lower Severe Disability	0 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 2 = Vegetative State	0 Participants
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) 1 = Dead	26 Participants

SECONDARY outcome

Population: All CTs were performed.

CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.

Outcome measures

Outcome data not reported

SECONDARY outcome

RTA = Road Traffic Accident

Outcome measures

Outcome measures
Measure	InfraScanner 2000™ and CT (Computerized Tomography) Scan n=387 Participants 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. 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.
Causes of Head Trauma as Identified Through the Medical Record RTA - Boda without helmet	179 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Boda with helmet	36 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Pedestrian hit by boda	24 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Pedestrian hit by car or bus	14 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Car without seatbelt	12 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Car unknown seatbelt	9 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Other	17 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Car with seatbelt	4 Participants
Causes of Head Trauma as Identified Through the Medical Record RTA - Boda unknown helmet	3 Participants
Causes of Head Trauma as Identified Through the Medical Record Assault	66 Participants
Causes of Head Trauma as Identified Through the Medical Record Fall	11 Participants
Causes of Head Trauma as Identified Through the Medical Record Other	6 Participants
Causes of Head Trauma as Identified Through the Medical Record Accidental Injury	4 Participants
Causes of Head Trauma as Identified Through the Medical Record Unknown	2 Participants

Adverse Events

InfraScanner 2000™ and CT (Computerized Tomography) Scan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 33 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony 'Tony' T. Fuller, MD, MScGH

Duke University

Phone: 919-613-1813

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place