An Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager for Detection of Intracranial Hemorrhage in the Acute Care Setting

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.