Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital: A Pilot Study
Phase: NA
Conditions: Head Trauma, Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Multiple, Head Injuries, Closed, Head Trauma,Closed, Head Trauma Injury, Head Trauma, Penetrating, Head Injury, Minor, Head Injury Major, Head Injury, Open, Injuries, Craniocerebral, Injuries, Head, Multiple Head Injury, Trauma, Head
Sponsor: Duke University

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
1. Title: Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-
Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural 
Hematomas in Patients Admitted to Duke University Hospital: A Pilot Study 
 
Principal Investigator: Michael Haglund, MD/PhD 
Co-Principal Investigator:  
Investigator:  
Investigator:  
Investigator:  
Investigator:  
Study Coordinator: Robert Gramer, BS 
Regulatory Coordinator:  
Regulatory Specialist:  
Statistician:  
 
2. Purpose of the Study: The goal of this study is to determine the sensitivity, 
specificity, and positive and negative predictive values of the 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 Duke University Hospital (DUH) 
who have sustained or who are suspected to have sustained head trauma and 
have consequently received a brain computed tomography (CT) scan(s).  
 
Traumatic brain injury (TBI) is a global pandemic that affects over 10 million 
people annually, with the incidence expected to continue to mushroom in coming 
years (1). Severe TBI often results in intracranial hematoma formation that can 
rapidly increase intracranial pressure (ICP). If the bleeding does not tamponade, 
failure to alleviate the escalating pressure results in irreparable brain damage, 
and often death. In the case of an expanding intracranial bleed, a burr hole or 
decompressive craniotomy provide the only recourse to limit further brain injury 
and avert death. Typically, such as decision needs to be made in hours, if not 
minutes, following the insult. In order to pursue such intervention, however, the 
presence of a surgically interveneable bleed must be confirmed, and moreover, 
the location of the bleed must be established.  
 
In industrialized nations, this is a trivial requirement, as CT scans are used 
ubiquitously to definitively diagnose EPH and SDH, readily and reliably triaging 
patients to surgical versus medical management. With 97% sensitivity, 98% 
specificity, 97% positive predicative value, 95% negative predictive value, and 
96% accuracy in diagnosing Intracranial hematomas, CT scanning is exquisitely 
effective at identifying or ruling out acute extra-axial, intracranial bleeds in 
patients who sustain head trauma, making a gold standard in acutely assessing 
traumatic brain injury (TBI) (2). As a result, head CT has become commonplace, 
if not universal in assessing head trauma in industrialized countries, where 
virtually every hospital has one, if not a dozen scanners. In less than 10 minutes, 
a CT scan can noninvasively prove or reject acute intracranial bleeding. They 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
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provide immediate insight into 1.) Whether there is in fact an intracranial bleed; 
2.)  In the case of a bleed, where below the cranium it has occurred and 3.) 
When done serially, gauge evolution, resolution, or stability of a bleed. This is 
invaluable information that directly impacts survival, as failure to perform a 
craniotomy in a patient with a rapidly expanding intracranial hematoma can 
swiftly lead to irreversible brain damage or even death. Moreover, performing 
such a surgery in the wrong location or in a patient who does not have a bleed 
amenable to surgical intervention can contribute extensive morbidity, 
exacerbating a patient’s already tenuous mortality.  
 
In less developed countries, CT scanners are often nonexistent. When they are 
present, they are extremely meager in number, peppered across treacherous 
geography, with scant transportation and emergency infrastructure. Even when 
accessible, they are commonly decommissioned due to a broken part, and are 
extremely cost prohibitive, with a single scan often costing the equivalent to 
multiple months’ income for the populations who need them most. As a 
consequence, in the settings where TBI pervades and brain imaging is most 
critical to survival, obtainment of such imaging is often unachievable.  
 
In resource-limited settings, techniques such as ultrasonic measurement of the 
optic nerve sheaths and latency of the pupillary reflex have been used to infer 
increased intracranial pressure. However, these techniques are notably crude. 
They provide no insight into the location or etiology of what is causing the 
presumed increase in pressure, typically indicate an ICP >30 but are poor at 
correlatively quantifying ICPs as they grow emergently high, and in the case of 
optic nerve sheath diameter specifically, take up to a day to manifest. Hence, 
while these modalities can corroborate that a particular patient has increased 
ICP, these techniques are inadequate in determining which patients stand to 
benefit from surgery, and for those who could, in informing the surgical approach 
that could save such patient’s lives.  
 
In 1997, the first ever handheld device that could definitively detect the presence 
and location of epidural and subdural hematomas was introduced (3). Initially 
named the Runman, the device was intended to detect intracranial hematomas in 
remote and military settings to triage which casualties should be airlifted to 
medical centers equipped to offer neurosurgery. After numerous iterations, the 
InfraScanner 1000™ was introduced in the mid 2000’s. In 2010, the pivotal five-
site double-blinded clinical trail was published, and ultimately led to FDA 
clearance of the InfraScanner 1000™. In the study, the Infrascanner 1000™ 
measurements were compared to CT scans of 365 patients, 96 of which were 
hematoma cases of various sizes, depths and locations. The study demonstrated 
high sensitivity (88%) in detecting hematomas > 3.5cc in volume and < 2.5 cm 
from the surface of the brain, and a specificity of 91%. Since then there have 
been numerous studies that have replicated these results and have substantiated 
that it is a capable tool for pre-hospital diagnosis of intracranial hematomas (3-
13).  

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
 
While these results are extremely promising, the InfraScanner devices’ utility has 
only been examined through the lens of pre-hospital decision-making. The 
sensitivity and specificity of the InfraScanner 2000™, introduced last year, has 
not been as exhaustively interrogated.  
 
As the sensitivity and specificity in detecting intracranial hematomas approaches 
that of CT scanning, the prospect of using the InfraScanner 2000™ as a stand-
alone diagnostic device for intracranial hematomas in low-resource settings that 
lack CT scans is highly intriguing. In geographical locations where TBI burden is 
highest and need for emergency craniotomies is most pressing, the inability to 
obtain CT scans precludes hundreds to thousands of life-saving surgeries 
everyday. The use of a handheld device that can be used repeatedly to reliably 
diagnose and track intracranial bleeding at no cost to a patient could 
revolutionize the prognosis of TBI for the majority of the 10 million people it 
affects annually.  
 
This project intends to show that the InfraScanner 2000™ is capable of detecting 
and ruling out intracranial hematomas in TBI patients at DUH at rates similar to 
CT scan. This work will hopefully justify the use of the InfraScanner 2000™ as a 
definitive diagnostic tool in determining surgical versus medical management in 
CT-barren settings, such as Uganda where our group, Duke Global 
Neurosurgery and Neurology has been building neurosurgical and neurological 
care capacity over the past decade.  
 
Aim 1: Determine whether the InfraScanner 2000™ detects epidural and/or 
subdural hematomas with adequate precision relative to CT scans to be used as 
a diagnostic tool for epidural and/or subdural hematomas.  
 
Aim 2: Use these findings to inform the feasibility of conducting a future trial in 
which the InfraScanner 2000™ is used as a stand-alone diagnostic tool for 
intracranial hematomas, and therein, to determine candidacy for decompressive 
craniotomies in patients who suffer traumatic brain injuries in places where CT 
scans are not available. 
    
 
3. Background and Significance: Traumatic brain injury (TBI) is a steadily 
growing global pandemic responsible for immense mortality and morbidity, 
particularly in low- and middle-income countries (LMIC’s). The World Health 
Organization (WHO) estimates that more than 10 million people sustain TBI 
resulting in death or significant irreversible deficits annually, the majority 
occurring in resource scarce settings. Most recent approximations suggest that 
Sub-Saharan Africa (SSA) bears the highest incidence of road traffic injury (RTI)-
associated TBI in the world. At a frequency of 170 per 100,000 people, TBI in 
SSA occurs at a rate 1.5 times that of the global average(1). A great 
preponderance of these injuries is comprised by intracranial hematomas; injuries 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
that would often stand to benefit from surgical intervention. However, the virtual 
nonexistence of CT scanners in the majority of settings where these injuries 
occur, preclude countless patients from receiving life-saving surgery.  
 
With approximately 90% of all injury-related deaths occurring in LMIC’s, this 
already enormous chasm in mortality is expected to only grow wider as 
obtainability of personal motor vehicles burgeons at rates far exceeding these 
economically-stifled nations’ faculties to build legislatorial, municipal, and medical 
infrastructure capable of equipoising the mushrooming incidence of TBI.  
 
Sub-Saharan Africa’s unprecedented paucity of medical resources is especially 
prominent in neurological care. At present there are 0.3 neurological beds, 0.03 
neurologists, and 0.01 neurosurgeons per 100,000 Africans. This can be 
contrasted with Europe where, per 100,000 citizens, there exist 17.1 neurological 
beds, 4.84 neurologists, and 2.43 neurosurgeons – a respective 57, 161, and 
243-fold resource disparity between these two continents. Even when compared 
to global averages, to which Africa’s and myriad other LMICs contribute, per 
capita, the world’s population benefits from greater than 12-times more 
neurological beds, 30-times more neurologists, and 56-times more 
neurosurgeons per capita than the average African (14).   
 
Taking Uganda, where our group, Duke Global Neurosurgery and Neurology, has 
worked for over the past decade to bridge this gap, motorbikes pervade the 
landscape with motorbike accidents contributing the lion’s share of the country’s 
TBI. From a strictly commercial perspective, there are currently over 300,000 
boda-bodas, or motorbike taxis, in Uganda’s capital city of Kampala – a 
comparable number to the total motorcycle registration in New York State, which 
has an area 750-fold larger than Kampala. Despite the highly visible mortality 
and introduction of a countrywide helmet law, helmet usage remains 31% and 
1% among drivers and passengers, respectively. In Uganda alone, this leads to 
tens of thousands of deaths due to head injuries every year.  
 
Many of these lives could be saved with prompt imaging and surgical 
intervention; however, CT scans are far too expensive (for both the government 
as well as patient) to introduce on a national scale throughout Uganda or 
similarly resource-scarce settings. With myriad lives lost due to lack of access to 
prompt brain imaging, an economically feasible alternative to CT scan must be 
validated to begin saving these tens to hundreds of thousands of otherwise 
savable lives lost annually in LMICs.  
 
Based upon the scant literature regarding TBI within SSA, Uganda experiences 
among the highest rates of TBI and TBI-related mortality in the world. A recent 
study conducted in the intensive care unit (ICU) at Mbarara Regional Referral 
Hospital (MRRH), which serves the Western Region of Uganda, Rwanda, 
Eastern Democratic Republic of Congo, and northwestern Tanzania, revealed 
that head injury accounts for 74% of adult and 69% of pediatric trauma cases, 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
with an overall mortality of 60% for patients admitted to the ICU with head 
trauma(15). For comparison, a 2006 UK study showed that in head injury 
patients requiring intensive care, 77% survived to leave the ICU and a 67% 
survived to leave hospital, an ICU mortality rate nearly three-fold less than that 
seen in Mbarara (16). A 2014 Finish study with a similar ICU survivability of 79%, 
reported an additional 12% mortality in the same population at 6-months(17). 
While no long-term TBI survivability data exists for LMIC’s, granted such 
significant post-discharge fatality in settings replete with vanguard healthcare 
resources and armed with robust long-term nursing and rehabilitative capacities, 
the ultimate survivability from severe TBI in SSA is presumably exceedingly rare. 
And at MRRH specifically, where in-patient mortality is unsurpassed and sub-
acute convalescent services are nonexistent, this geographically vast TBI 
population assumes as bleak a fate as anywhere in the world.   
 
Our group, Duke Neurosurgery and Neurology (DGNN), has been a unique 
presence in Uganda as well as SSA at large, traveling to Mulago National 
Referral Hospital (MNRH) in Kampala since 2007 to provide neurosurgical 
resources and training to local surgeons and trainees, expanding our outreach to 
Mbarara both of the past two years as well as Megno Hospital over the past year. 
To date, the DGNN has delivered 71 tons of medical equipment valued at $9.5 
million to MNRH and $1 million to MRRH. Through the DGNN, the country’s first 
neurosurgical residency program was established, which has since trained two 
neurosurgeons, increasing the country’s total workforce by 50%, with six more 
currently being trained, with a goal by 2022 to have eight neurosurgical units with 
twenty neurosurgeons stationed within major district hospitals all across 
Uganda. This pursuit has afforded the group an exceptional relationship with the 
hospitals’ administrators and personnel as well as the Ugandan Ministry of 
Health, while producing a gargantuan responsibility to build comprehensive 
neurological care for the population.  
 
Despite the significant progress of the DGNN in helping to build neurosurgical 
capacity in Uganda, the non-operative and postoperative critical care for severely 
neurologically injured patients has remained largely unchanged, with, as 
mentioned above, reported mortality outcomes at MRRH as poor as anywhere in 
the world (15). While our work has improved neurosurgical care for any individual 
patient, and is steadily continuing to broaden access to neurosurgical care to the 
nation, the inability to readily diagnose intracranial bleeding in emergency 
situations has stifled the ability to furnish emergency neurosurgical care.  
 
Over the past three years the DGNN has grown from a staff of 6 to a workforce of 
over 60, most notably adding three neurointensivists, two emergency medicine 
physicians, a neuropsychologist, an epidemiologist, as well as numerous 
anesthesiologists and nurses. Of particular note, the primary author reporting the 
dire outcomes at MRRH is Dr. Stephen Ttendo, the Chair of Anesthesiology at 
MRRH, the President of the Association of Anesthesiologists of Uganda, and the 
Chief of MRRH’s ICU, and maintains unwavering dedication to improving 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
outcomes at MRRH. While he could be directing the department at an urban 
hospital where the resources are superior, the pay is greater, and the outcomes 
are better, he has chosen to dedicate his life’s work to rural Uganda because that 
is where he sees the greatest healthcare need and capacity for improvement. In 
accord with this vision, the DGNN sees an undeniable niche at MRRH to 
establish a cost-effective, sustainable ICU that can dramatically reduce mortality. 
With readily available imaging as a cornerstone, this will hopefully lay the 
foundations for an international neurological referral hospital, while producing a 
highly practical critical care model that can be replicated in other LMIC’s. 
 
With a median age of 15.7 years, Uganda is second only to Niger in youth of its 
population. Currently, 69% of the Ugandan population is under the age of 25, and 
an estimated 80% of all Ugandans between 20 and 30 years earn a living by 
taxiing passengers. Granted the already globally unprecedented motorbike 
usage, the cultural ambivalence toward helmets, haphazard law enforcement, 
and still increasing motorbike density, the already appalling incidence of TBI is 
inevitably going to upsurge in coming years.  
 
In Uganda, there are currently 33 ICU beds, 6 government neurosurgeons, and 1 
formally trained neurologist to serve, not accounting for the significant 
international referrals received from neighboring countries, the entire population 
of 41 million people (18, 19). Despite the profound dearth of care and 
exceptionally high mortality, Africans pay significantly more out of pocket for 
medical care than the world (83% versus 26%), which in the case of current TBI 
care, often leads to incurrence of significant familial hardship for improbable 
survival (14). This constellation of unmatched mortality, resource famine, and 
debt incurrence fashion SSA, and MRRH in particular, the ideal setting to pilot a 
minimal-resource, guideline-driven ICU system. The InfraScanner 2000™ can 
potentially server as the centerpiece of such a system providing zero-cost, 
immediately-available, sequential intracranial imaging to help make urgent 
surgical and medical decisions that can save an untold number of lives that are 
currently being forfeited due to lack of imaging.   
 
To work toward this, this study proposes compare the sensitivity, specificity, 
accuracy, and precision of the InfraScanner 2000™ against brain CT scans at 
DUH. If capable detecting Intracranial hematomas with efficacy similar to CT, 
expanding the use of the such a device as a CT-substitute to detect intracranial 
hematomas in places devoid of CT facilities could revolutionize TBI care in 
LMICs.    
 
4. Design and Procedures: 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 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
procedure will be explained in detail, using an IRB-approved verbal consent 
“script”, 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. When subjects are approached for subsequent study 
measurements, if the subject has regained the capacity to consent or has an 
LAR present, the verbal script will be used to obtain consent.  Subjects will be 
asked at that time if prior measurements obtained may be used in the research. 
 
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), Duke Box, 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.  
 
5. Selection of Subjects: Any patient, who presents to DUH with suspected head 
trauma who receives a brain CT scan will be considered for this study. Patients 
who are candidates for emergent surgical treatment (i.e. measurements cannot 
be obtained in the time while awaiting the results of the CT scan) will not be 
approached. 
 
6. Subject Recruitment and Compensation: The research team will approach 
potential research participants only after gaining permission from the physician in 
charge of the patient’s care. No compensation will be provided for participation in 
this study. Whenever possible, the study will be explained to the patient and/or 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
associated parties, and someone from the study team will always be available to 
answer any questions regarding the study.  
  
7. Consent Process: We are requesting waiver for informed consent (when the 
patient is unable to consent and no LAR is available) for this pilot study as 1.) It 
poses no perceptible risk to the patient’s health and does not influence his or her 
care in any appreciable way; 2.) The majority of the patients of interest will be 
unconscious or mentally altered due to their presenting injury or medical 
condition. This will often times occur in an emergent setting where legal 
representatives, family, guardians, or other stewards will not be present within 
the timeframe required to obtain usable data. A verbal consent process will be 
used whenever the patient is able to consent or a legally authorized 
representative is present.  Consent, or the decision not to participate, will be 
documented in the patient’s chart. 
 
Validating that this device can reliably identify intracranial bleeds can 1.) 
Streamline the care of persons who sustain traumatic brain injuries in resource-
replete settings, such as a Duke patient, through providing insight into the extent 
and location of intracranial trauma in a pre-hospital setting, facilitating 
expeditions care upon arriving to the hospital; 2.) Revolutionize traumatic brain 
injury care and prognosis in resource-poor settings where CT scanners are not 
readily available (i.e. Uganda) by providing prompt intracranial imaging that is 
otherwise impossible to obtain, thus affording life-saving surgical intervention 
when warranted.  
  
  
8. Subject’s Capacity to Give Legally Effective Consent: We expect that most of 
the subjects will be neurologically and/or cognitively impaired due to extent of 
head injury, multisystem trauma, and/or medical treatments. The study will be 
offered to patients 0 years of age and older. Since this is a minimal risk study in 
which we are de-identifying all patient data, with no conceivable risks to the 
patients or deterrents to the patients’ standard of care, we are not requiring 
written consent for this study, however verbal declination by the patient or a 
patient representative will preclude any data collection. Consent or declination 
will be documented in the patient’s chart. For patients younger than 18 years, we 
will speak with the parents whenever possible, and obtain their verbal permission 
to obtain each scan.  
  
9. Study Interventions: As described above, within 30 minutes following each CT 
scan, the study subject’s cranium will be scanned with the InfraScanner 2000™ 
(Image A). To do so, 8 plastic light guides will be placed 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 underlying 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 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
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 study team will 
approach the patient within a 30-minute window following each CT scan, and 
when feasible, a comparative measurement with the InfraScanner 2000™ will be 
obtained.  
 
10.  Device Description/Mechanism: The following description is adapted from the 
InfraScanner White Paper (20): All biological tissue is, to differing extent, 
permeable to electromagnetic radiation of different frequencies and intensities. 
This can also be considered permeability to photons of different energy levels. 
This permeability to electromagnetic energy is the basis of all imaging based on 
transmission/scattering characteristics such x-ray, Computed Tomography, and 
near-infrared, NIR, imaging. From the principles of spectroscopy, it is also known 
that different molecules absorb different wavelengths of electromagnetic radiation 
(which is synonymously referred to as light at shorter wavelengths). Similarly, 
tissue scatters radiation to different degrees. The Infrascanner is concerned with 
NIR imaging of the hemoglobin molecules. From any light source, photons follow 
a characteristic path through the target tissue back to a detector on the same 
approximate plane as the source. While the light is severely attenuated due to 
the scattering and absorption process, it is nonetheless encoded with the 
spectroscopic signatures of the molecules encountered en route to the detector 
(Image C).      
 
The principle used in identifying intracranial hematomas with the Infrascanner is 
that extravascular blood absorbs NIR light more than intravascular blood. This is 
because there is a greater (usually 10-fold) concentration of hemoglobin in an 
acute hematoma than in normal brain tissue where blood is contained within 
vessels. The Infrascanner compares left and right side of the brain in four 
different areas. The absorbance of NIR light is greater (and therefore the 
reflected light less) on the side of the brain containing a hematoma, than on the 
uninjured side. With specified wavelength ranges, optical light source(s) or 
emitter(s) and a photodetector are placed at a distance, which allows proper 
NIRS absorption measurements in a desired volume of tissue. The wavelength of 
805nm is sensitive only to blood volume, not to oxygen saturation in the blood 
(Image D).    
 
 
The Infrascanner is placed successively in the left and right frontal (F), temporal 
(T), parietal (P), and occipital (O) areas of the head and the absorbance of light is 
recorded. Specifically the placement is as follows: 
 
Frontal Left/Right forehead, above the frontal sinus; Temporal In the Left/Right 
temporal fossa; Parietal Above the Left/Right ear, midway between the ear and 
the midline of the skull; Occipital Behind the Left/Right ear, midway between the 
ear and the occipital protuberance (Image B). 

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Dr. Michael Haglund 
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The difference in optical density (ΔOD) in each of the four symmetrical areas is 
calculated on a pair-wise basis from the following formula:  
 
 
 
where IN = the intensity of reflected light on the normal side, IH = the intensity of 
reflected light on the hematoma side.  
 
In summary: The Infrascanner includes three components: (1) the Scanner, (2) 
the Disposable Shield and (3) a Cradle. The Scanner includes a safe NIR diode 
laser and a silicon detector. The light to and from the laser and detector are 
optically coupled to the patient’s head through the disposable shield optical 
fibers. The optical fibers are long enough to reach through hair and contact the 
scalp. The optical fibers are placed 4 cm apart allowing optimal detection of 
hematomas. The extended fiber optics eliminates the need to shave off any hair. 
And because the fiber optic piece is disposable it prevents cross contamination. 
The detected light passes through an optical NIR band-pass filter in order to 
minimize background light interference. Electronic circuitry is included to control 
laser power and the detector signal amplifier gain. The detector signal is digitized 
and analyzed by a single board computer, SBC, in the Scanner. The SBC 
receives the data from the detector and automatically adjusts the settings of the 
Scanner to ensure good data quality. The data is further processed by the SBC 
and the results are displayed on the screen. Readout of the scan provides 
information on the severity of a hematoma and identifies the region of the brain 
bleeding. A higher optical density in the scanned region indicates a larger 
hematoma (20). 
 
11. Risk/Benefit Assessment: There are neither any specific clinical benefits to the 
research participant, nor are there any direct incentives, financial or otherwise, 
provided to the research participant. There is no known health risk of interval, 
short-term use of the device.  
 
12. Costs to the Subject: No additional costs to the patient will be incurred as a 
result of this add-on, intraoperative research protocol.  
 
13. Statistical Considerations: Objectives: The primary objective of this study is to 
estimate the test characteristics (sensitivity, specificity, and the false positive and 
false negative rates) of the portable NIR-based device (InfraScanner 2000™) in 
the identification of any size hematoma among patients hospitalized at DUH who 
have sustained or who are suspected to have sustained head trauma and have 
consequently received a brain CT scan(s). The results of the CT scan(s) will 
serve as the gold standard. The sensitivity, specificity, and the false positive and 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
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false negative rates will be estimated at the patient level and at the scan level. 
Approximately 90% of patients are expected to have more than one CT scan. 
 
A secondary objective is to estimate the test characteristics of the InfraScanner 
2000™ in identification of hematomas within its detection limits (volume >3.5 mL 
and depth <2.5 cm) compared to CT scan results as the gold standard. 
 
Exploratory objectives include: 
1. Examining the impact of factors such as hematoma type, location, and 
patient age on test characteristics of the InfraScanner 2000™ 
2. Determining the minimum resolution detectable by the InfraScanner 
2000™ 
3. Estimating Receiver Operating Characteristic (ROC) curves with patient 
and scan as the units of analysis (21). 
  
Study Design: 
a) Eligibility: 
Any patient who presents to DUH with suspected head trauma and 
receives a brain CT scan will be considered for this study. Based on 
previously reported data, we expect that SDH or EDH will be present in 
approximately 20% of patients overall. 
 
b) Standard of comparison: 
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.   
 
 
Definitions of Sensitivity, Specificity, False Positive, False Negative 
Let A+ denote the event that the test is positive for hematoma and B+ 
denote the event that a hematoma is present. Sensitivity, P(A+/B+), will be 
defined for each patient (scan) as the probability that a true hematoma as 
determined by CT scan will be detected (22).  Similarly, let A- denote the 
event that the test is negative for hematoma and B- denote the event that 
a hematoma is not present. Specificity, P(A-/B-), will be defined as the 
probability of being negative for hematoma on the InfraScanner 2000™ 
scan within 30 minutes of CT given the patient has no hematoma present.   
 

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The false positive rate will be defined as PF+ = P(B-/A+) = P(A+/B-)[1-
P(B+)]/P(A+).  Similarly, the false negative rate will be defined as PF- = 
P(B+/A-) = [1-P(A+/B+)]P(B+)/[1-P(A+)].  Estimates for the false positive and 
false negative rates will be provided for a range of values for the 
prevalence of hematomas. 
 
c) Sample Size 
Computation of the required number of patients is based on estimating the 
sensitivity of each method to within at most +/- 0.10 with 90% confidence.  
The 90% confidence interval for the sensitivity is given by PSens +/- 
1.645*SE(PSens) where SE(PSens)= [(PSens)(1- PSens)/N; N denotes the 
number of true positives.  
 
Administrative Summary: Based on an interim analysis conducted after 
200 patients were studied, the proportion of patients with hematomas is 
0.13. This is lower than the 20% originally expected. The sample size 
computation was thus revised as follows. 
 
Original sample size computation  
With 68 patients with positive findings of hematoma, sensitivity can be 
estimated to within at most +/- 0.099 with 90% confidence.  Assuming 
20% of patients have true hematomas detected, 340 patients must be 
accrued (10).  Allowing for a 5% dropout rate the required sample size for 
this trial is 360 subjects. With 272 patients having negative findings for 
hematoma, specificity can be estimated to within at most +/- 0.05 with 
90% confidence. 
 
Revised sample size computation 
With 68 patients with positive findings of hematoma, sensitivity can be 
estimated to within at most +/- 0.099 with 90% confidence.  Assuming 
13% of patients have true hematomas detected, 523 patients must be 
enrolled to observe positive findings in 68 patients. With 455 patients 
having negative findings for hematoma, specificity can be estimated to 
within at most +/- 0.038 with 90% confidence. 
 
d) Interim Analysis 
An interim analysis will be conducted once 150 patients have been 
enrolled on study to estimate the prevalence of hematomas at DUH. The 
adjusted 90% confidence interval estimate for sensitivity will also be 
constructed.  Based on these results the trial may be amended to enroll 
fewer or more patients. 
 
e) Accrual 
It is anticipated that at least 60 patients per month will be accrued and 
studied at DUH. Study enrollment should thus be completed within 
approximately 6 months. Patients will be followed for up to 30 days 

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following the initial measurement with the InfraScanner 2000™, discharge, 
or death whichever occurs first. We do believe this figure is feasible, as 60 
head CT scans at DUH is less than the quoted number of 80 by the 
manager of head CT at Duke. 
 
This target monthly number for enrollment, though ambitious, is feasibly 
obtainable. This number is less than the estimated number of head CT 
scans obtained at DUMC per month (~80), as quoted by the manager of 
CT services at Duke. Furthermore, this is the number of all head CT 
scans, not just those that have evidence of EDH/SDH, at Duke as we 
intend to show positive and negative predictive value of the InfraScanner 
2000™, to rule in and rule out EDH/SDH. Thus with the buy in from the 
team, we believe that 60 scans per month is a robust but realistic target. 
 
 
Data and Safety Monitoring: Patients will be under continuous supervision 
during the entirety of each data collection period. Outside the ~10 minute window 
of each collection period, the patient is not subjected to any research intervention 
or influenced by the research in any way. As part of their treatment, patients will 
be under hospital care for their diagnoses for which they were admitted, and the 
research team will be in continual contact with the team regarding their clinical 
status and enrollment in the study. These data will be stored in de-identified form 
on REDCap, Duke Box, and/or Microsoft Excel 2016 on a secured DHTS server 
(S:\NSU_IRB\Pro00087011). Temporary documentation of MRNs and CT scan 
dates/times will be stored on an excel spreadsheet saved on the secure network 
drive as described in the RDSP.  Once the MRNs and CT scan dates/times from 
Maestro Care are assigned a unique protocol ID, only de-identified data will be 
documented and the temporary excel spreadsheet destroyed upon statistical 
analysis (to ensure data is complete). 
 
The PI will be responsible for securing and monitoring the data, including a 
quarterly review of data storage procedures. The data will be stored  
 
14. Privacy, Data Storage, and Confidentiality: Patients will be numbered as 
experimental subjects. Data will be stored on a HIPAA-compliant DHTS-
maintained server (S:\NSU_IRB\Pro00087011) within a REDCap repository, 
Duke Box, and/or Microsoft Excel 2016 database. Data used for analysis on local 
machines within the Department of Neurosurgery will be fully de-identified. 
Experimenters’ notes will be stored in a locked cabinet in the PI's office in the 
Department of Neurosurgery and in digital form on the DHTS-maintained server. 
Patient’s protected health information or any information that can be used to 
uniquely identify an individual patient will be temporarily stored in the protected 
network drive until a unique study code is assigned and then destroyed. The key 
to the unique code will be stored in the locked cabinet in the PI’s office.  
Regulatory binders are stored with the CRC in Dr. Michael Haglund’s office. 
 

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Image A (20) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Image B (20) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Image C (20) 
 
 
Image D (20) 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
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References 
1. 
Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact 
of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53. 
2. 
Islam SA-A, S.; Habib, A.; Alam, R.; Bhuiyan, M. Computed Tomographic Evaluation of 
Traumatic Epidural and Subdural Haematoma with Post Operative Correlation. Bangladesh 
Journal of Radiology and Imaging. 2009;17(2):40-5. 
3. 
Robertson CSGSPCB. Use of Near-Infrared Spectroscopy to Identify Traumatic 
Intracranial Hematomas. Journal of biomedical optics. 1997;2:33-41. 
4. 
Braun T, Kunz U, Schulz C, Lieber A, Willy C. [Near-infrared spectroscopy for the 
detection of traumatic intracranial hemorrhage: Feasibility study in a German army field 
hospital in Afghanistan]. Der Unfallchirurg. 2015;118(8):693-700. 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
5. 
Bressan S, Daverio M, Martinolli F, Dona D, Mario F, Steiner IP, et al. The use of 
handheld near-infrared device (Infrascanner) for detecting intracranial haemorrhages in 
children with minor head injury. Child's nervous system : ChNS : official journal of the 
International Society for Pediatric Neurosurgery. 2013. 
6. 
Francis SV, Ravindran G, Visvanathan K, Ganapathy K. Screening for unilateral 
intracranial abnormalities using near infrared spectroscopy: a preliminary report. Journal 
of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 
2005;12(3):291-5. 
7. 
Leon-Carrion J, Dominguez-Roldan JM, Leon-Dominguez U, Murillo-Cabezas F. The 
Infrascanner, a handheld device for screening in situ for the presence of brain haematomas. 
Brain injury. 2010;24(10):1193-201. 
8. 
Peters J, Van Wageningen B, Hoogerwerf N, Tan E. Near-Infrared Spectroscopy: A 
Promising Prehospital Tool for Management of Traumatic Brain Injury. Prehospital and 
disaster medicine. 2017;32(4):414-8. 
9. 
Robertson CS, Gopinath SP, Chance B. A new application for near-infrared 
spectroscopy: detection of delayed intracranial hematomas after head injury. Journal of 
neurotrauma. 1995;12(4):591-600. 
10. 
Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, et al. Clinical 
evaluation of a portable near-infrared device for detection of traumatic intracranial 
hematomas. Journal of neurotrauma. 2010;27(9):1597-604. 
11. 
Salonia R, Bell MJ, Kochanek PM, Berger RP. The utility of near infrared spectroscopy 
in detecting intracranial hemorrhage in children. Journal of neurotrauma. 
2012;29(6):1047-53. 
12. 
Xu L, Tao X, Liu W, Li Y, Ma J, Lu T, et al. Portable near-infrared rapid detection of 
intracranial hemorrhage in Chinese population. Journal of clinical neuroscience : official 
journal of the Neurosurgical Society of Australasia. 2017;40:136-46. 
13. 
Zhang Q, Ma H, Nioka S, Chance B. Study of near infrared technology for intracranial 
hematoma detection. Journal of biomedical optics. 2000;5(2):206-13. 
14. 
Janca A, Aarli JA, Prilipko L, Dua T, Saxena S, Saraceno B. WHO/WFN Survey of 
neurological services: a worldwide perspective. Journal of the neurological sciences. 
2006;247(1):29-34. 
15. 
Ttendo SS, Was A, Preston MA, Munyarugero E, Kerry VB, Firth PG. Retrospective 
Descriptive Study of an Intensive Care Unit at a Ugandan Regional Referral Hospital. World 
journal of surgery. 2016. 
16. 
Hyam JA, Welch CA, Harrison DA, Menon DK. Case mix, outcomes and comparison of 
risk prediction models for admissions to adult, general and specialist critical care units for 
head injury: a secondary analysis of the ICNARC Case Mix Programme Database. Critical 
care (London, England). 2006;10 Suppl 2:S2. 
17. 
Raj R, Skrifvars M, Bendel S, Selander T, Kivisaari R, Siironen J, et al. Predicting six-
month mortality of patients with traumatic brain injury: usefulness of common intensive 
care severity scores. Critical care (London, England). 2014;18(2):R60. 
18. 
Kwizera A, Dunser M, Nakibuuka J. National intensive care unit bed capacity and ICU 
patient characteristics in a low income country. BMC research notes. 2012;5:475. 
19. 
Lanyero F. Mulago Hospital has only four neurosurgeons. Daily Monitor. 2013. 
20. 
InfraScan. InfraScanner White Paper. In: InfraScan, editor. Online2014. 

InfraScanner Summary NCT03353246 
Dr. Michael Haglund 
Pro00087011_Research_Summary_20180507 (5)_For CT.gov Upload 
21. 
Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating 
characteristic (ROC) curve. Radiology. 1982;143(1):29-36. 
22. 
JL F.  Statistical Methods for Rates and Proportions. Second ed. New York, New York: 
John Wiley & Sons; 1981. p. 1-18.