Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)

Traumatic Brain Injury [TBI] has become the hallmark injury of modern warfare and remains one of the most challenging conditions to diagnose in forward-deployed care settings. One of the primary obstacles in diagnosing TBI on the battlefield is the "silent" or delayed onset of neurological symptoms, which can mask the severity of the injury. A key contributor to poor outcomes in moderate to severe TBI is the presence of acute intracranial bleeding, which can swell rapidly, leading to secondary brain damage or death. Early identification of such bleeds is critical for improving patient survival and neurological recovery.

Currently, CT is the gold standard for diagnosing intracranial hemorrhage [ICH], providing the accuracy needed to detect and evaluate brain bleeds. However, the logistical requirements of CT imaging pose significant challenges in deployed or resource-limited environments. These demands render CT impractical for field use, leaving forward-operating medical personnel without a reliable imaging solution for rapid TBI diagnosis. Consequently, there is a pressing need for portable, point-of-injury [POI] diagnostic tools that can effectively detect brain injuries in austere settings.

In both military and civilian contexts, there is an unmet need for a diagnostic device that can alert medical personnel to changes in ICH status without relying on resource-intensive serial imaging or neurological monitoring. Such a tool could enable timely triage and inform critical medical evacuation decisions, improving outcomes for patients with TBI. Existing POI technologies, however, predominantly rely on functional assessments and indirect measures of TBI, which are inherently subjective and often lack specificity. The reliance on such methods can result in false positives or negatives, particularly in low-incidence injuries, where positive predictive value [PPV] tends to fall below 50%. In military medicine, ensuring high sensitivity and specificity is crucial, as initiating unnecessary treatment or evacuations can impose significant operational risks and resource costs. A field-ready diagnostic tool capable of accurately identifying ICH and other TBI complications is therefore essential for improving care in both military and civilian emergency settings.

Existing POI technologies, however, predominantly rely on functional assessments and indirect measures of TBI, which are inherently subjective and often lack specificity. The reliance on such methods can result in false positives or negatives, particularly in low-incidence injuries, where positive predictive value [PPV] tends to fall below 50%. In military medicine, ensuring high sensitivity and specificity is crucial, as initiating unnecessary treatment or evacuations can impose significant operational risks and resource costs. A field-ready diagnostic tool capable of accurately identifying ICH and other TBI complications is therefore essential for improving care in both military and civilian emergency settings.

Near-Infrared Spectroscopy [NIRS] can be used to interrogate tissue. It has been well studied over the years and it can be shown that the principal components of variation in intensity response from tissue can be ascribed to blood volume and oxygenation. The reflected light from the NIR source is used to determine the presence of blood volume in the tissue beneath the sensor. By comparing tissues from different locations within the brain the presence of large volumes of blood that represent a pathological event can be detected. The use of near infra-red [NIR] to estimate the presence of intracranial bleeding spectroscopically has been previously demonstrated, with high agreement with traditional head CT. Though effective for detection of a statichemorrhagic event, there are no currently available NIR-based technology that employs dynamic structural imaging. Moreover, current tools cannot reliably diagnose all types of hematomas, particularly bilateral head injuries.

IMPACT AND RELEVANCE. Approximately 60% of wounded soldiers sustain blast injuries and two-thirds are diagnosed with a TBI. While the majority of TBIs are mild and nonfatal, 17-20% of severe TBI patients die within the first 24 hours after injury underscoring the importance of rapid assessment and accurate triage. Of those who survive the acute phase of a TBI, up to 57% experience chronic health problems related to their injury. This translates to a great economic burden and severe reduction of quality of life for millions of Service Members, Veterans, and civilians. Demonstration of a rapid triage tool for ICH resulting from TBI may expedite diagnosis and treatment, which could minimize the adverse consequences of TBI. Alternatively, the device could rule out injuries for which medical evacuation is non-emergent, preserving Force resources. Advancement of POI diagnostic tools hinges on the demonstration of the efficacy and feasibility of the tool in the acute care setting. In alignment with the goals of conducting high impact translational research that will accelerate innovative ideas into clinical applications that are relevant to Service Members, Veterans, and their families, this study aims to provide critical performance evaluation for the NIRD HI in a US population of TBI patients. Although this study will be conducted in level I trauma center, the questions addressed are applicable to military practice, prolonged field care in particular. Current Joint Trauma System Clinical Practice Guideline [JTS CPG)] for TBI management in prolonged field care [CPG ID: 63] rely on specialized assessments and/or equipment to detect raised intracranial pressure resulting from an ICH. Earlier detection of an intracranial bleed, prior to clinical deterioration, could change triage priorities and inform medical evacuation plans, key to decreasing mortality and improving functional outcomes and quality of life.

Inclusion criteria

• 18 to 89 years of age
• Able to provide written informed consent either by self or legally authorized representative
• Received head CT imaging on admission
• Able to complete at least one NIRD-HI scan within 4 hours of head CT
• Non-operative management planned

Exclusion criteria

• Presence of penetrating or non-survivable injuries
• Hemorrhagic shock or large volume transfusion [>3 units of any blood product within

1 hour of scan]

• Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement
• Presence of heat tattoos or intracranial metal fixtures
• Cervical injury prolonging C-spine collar
• Known prisoners or wards of state
• Any condition or finding that makes the patient unsuitable for image acquisition in the Investigator's opinion