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

Официальное название

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

Обзор

Traumatic Brain Injury (TBI) is a leading cause of death and disability among military personnel, Veterans, and civilians. One of the most dangerous complications of moderate-to-severe TBI is intracranial hemorrhage (ICH). If not identified and treated promptly, ICH can rapidly lead to worsening neurological damage or death. Current diagnostic tools, such as CT scans, are highly effective but impractical for battlefield or resource-limited environments due to their large size and infrastructure dependency. The Near-Infrared Detection-Head Imaging (NIRD-HI) system is an innovative, noninvasive device using Near-Infrared Spectroscopy (NIRS) to identify abnormal blood accumulation. Unlike traditional tools, NIRD-HI is compact, lightweight, and portable, making it suitable for remote or austere settings. By dynamically imaging the brain, it generates 3D visualizations that pinpoint the size and location of bleeds, including complex bilateral injuries. This offers a significant improvement over current point-of-injury technologies that lack the resolution to reliably diagnose all forms of ICH. This study supports the FY24 Combat Readiness Medical Research Program by advancing battlefield diagnostic and triage capabilities. The research will: * Evaluate NIRD-HI's accuracy compared to CT imaging. * Assess feasibility in real-world acute care settings. * Investigate its ability to monitor changes in ICH over time. These objectives address the military's need for tools that improve rapid diagnosis and decision-making during emergencies. Implementing this research can revolutionize TBI management. For Service Members, NIRD-HI promises a field-ready solution for early detection, enabling faster intervention and more effective triage. By reducing diagnostic delays, it could save lives and prevent long-term complications. Furthermore, the system supports prolonged field care by providing continuous monitoring of evolving injuries. The benefits extend to civilian healthcare, particularly in rural or underserved areas lacking advanced imaging. This accessibility can improve trauma care outcomes for millions, reduce the burden on healthcare systems, and provide equitable distribution of life-saving technology. By addressing gaps in battlefield medicine, this project aims to enhance medical readiness and improve survivability in the most challenging environments.

Подробное описание

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.

Вмешательства

• Диагностический тест NIRD-HI scan at the time of enrollment
  All enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.
• Диагностический тест Secondary NIRD-HI scan when a planned repeat CT is performed
  For patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.

Первичные конечные точки

• Diagnostic Performance [Срок оценки: Baseline, at time of NIRD-HI testing administered]
• Feasibility Assessment - Scan Time [Срок оценки: Enrollment through study completion, an average of 1 year]
• Feasibility Assessment - Operator Usability [Срок оценки: Near the end of recruitment period, an average of 1 year]
• Feasibility Assessment - Device Integration [Срок оценки: Enrollment through study completion, an average of 1 year]
• Monitoring of ICH Progression [Срок оценки: Baseline, at time of NIRD-HI testing administered]

Вторичные конечные точки (3)

• Diagnostic Performance - Time Detection of ICH [Срок оценки: Baseline, at time of NIRD-HI testing administered]
• Diagnostic Performance - Operator Performance [Срок оценки: Baseline, at time of NIRD-HI testing administered]
• Accuracy of evolution testing [first NIRD HI scan vs. second NIRD HI] [Срок оценки: Baseline, at time of NIRD-HI testing administered]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Brooke Army Medical Center — San Antonio

Публикации

• Peterson, Alexis B. et al. (2019). Surveillance report of traumatic brain injury-related emergency department visits, hospitalizations, and deaths, United States, 2014. Available from: www.cdc.gov/traumaticbraininjury/get_the_facts.html
• Law ZK, Dineen R, England TJ, Cala L, Mistri AK, Appleton JP, Ozturk S, Bereczki D, Ciccone A, Bath PM, Sprigg N; TICH-2 investigators. Predictors and Outcomes of Neurological Deterioration in Intracerebral Hemorrhage: Results from the TICH-2 Randomized Controlled Trial. Transl Stroke Res. 2021 Apr;12(2):275-283. doi: 10.1007/s12975-020-00845-6. Epub 2020 Sep 9. PMID 32902808
• McCredie VA, Chavarria J, Baker AJ. How do we identify the crashing traumatic brain injury patient - the intensivist's view. Curr Opin Crit Care. 2021 Jun 1;27(3):320-327. doi: 10.1097/MCC.0000000000000825. PMID 33852501
• Fletcher-Sandersjoo A, Tatter C, Tjerkaski J, Bartek J Jr, Maegele M, Nelson DW, Svensson M, Thelin EP, Bellander BM. Time Course and Clinical Significance of Hematoma Expansion in Moderate-to-Severe Traumatic Brain Injury: An Observational Cohort Study. Neurocrit Care. 2023 Feb;38(1):60-70. doi: 10.1007/s12028-022-01609-w. Epub 2022 Sep 27. PMID 36167951
• Tien HC, Jung V, Pinto R, Mainprize T, Scales DC, Rizoli SB. Reducing time-to-treatment decreases mortality of trauma patients with acute subdural hematoma. Ann Surg. 2011 Jun;253(6):1178-83. doi: 10.1097/SLA.0b013e318217e339. PMID 21494125
• Kainerstorfer JM, Ehler M, Amyot F, Hassan M, Demos SG, Chernomordik V, Hitzenberger CK, Gandjbakhche AH, Riley JD. Principal component model of multispectral data for near real-time skin chromophore mapping. J Biomed Opt. 2010 Jul-Aug;15(4):046007. doi: 10.1117/1.3463010. PMID 20799809
• Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, Garza H, Maloney-Wilensky E, Plaum JM, Koenig CH, Johnson A, Morgan T. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010 Sep;27(9):1597-604. doi: 10.1089/neu.2010.1340. PMID 20568959
• Gramer R, Shlobin NA, Yang Z, Niedzwiecki D, Haglund MM, Fuller AT. Clinical Utility of Near-Infrared Device in Detecting Traumatic Intracranial Hemorrhage: A Pilot Study Toward Application as an Emergent Diagnostic Modality in a Low-Resource Setting. J Neurotrauma. 2023 Aug;40(15-16):1596-1602. doi: 10.1089/neu.2021.0342. Epub 2022 Aug 2. PMID 35856820

Идентификаторы

NCT: NCT07338383 · C.2026.013 · RC240162

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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