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NIRD-HI
An Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager for Detection of Intracranial Hemorrhage in the Acute Care Setting
Sponsor study identifier
Secondary identifiers
OTHER · CDMRP-eBRAP Log Number
observational
80
1 country
1
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 29, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 29, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2025
Actual (reported)January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 13, 2026
Actual (reported)September 29, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 29, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diagnostic Performance
Diagnostic Performance. Establish the sensitivity, specificity, PPV, and NPV of the NIRD-HI system for detecting ICH in TBI patients, with a target sensitivity and specificity exceeding 90%.
Baseline, at time of NIRD-HI testing administered
Feasibility Assessment - Scan Time
Time in minutes to complete scans in acute care setting recorded on a templated study log including scan start/stop time, interruptions and reasons for interruptions, technical errors and unanticipated device adverse events.
Enrollment through study completion, an average of 1 year
Feasibility Assessment - Operator Usability
Operator usability near the end of the recruitment period, 4-6 blinded clinicians (physicians and/or mid-level practritioners) will make a determination of criteria positive or negative research scans assigned in random order to establish statistics for inter-reader agreement. Blinded readers will assign a likelihood score using a Visual Analog Scale \[VAS\] to indicate how confident they are in their read.
Subjects with positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage
Subjects without positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage
All enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.
For patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.
Access to the proposed population includes a mixture of 15% active-duty military and/or VA patients and 85% civilians from central/southern Texas, including the 22 surrounding counties that are receiving trauma care at Brooke Army Medical Center. Daily review of the Trauma census will be conducted to review eligible patients. This screening tool will help determine, predict, and address challenges to recruitment.
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
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.
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.
Julie Rizzo, MD
Brooke Army Medical Center
First Submitted
December 3, 2025
First Posted
January 13, 2026
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 29, 2027
EstimatedNear the end of recruitment period, an average of 1 year
Feasibility Assessment - Device Integration
Device integration, through operator feedback questionnaire regarding ease of use.
Enrollment through study completion, an average of 1 year
Monitoring of ICH Progression
NIRD-HI readouts for the presence/absence of ICH and region of detection \[if positive\] as determined by the research device. NIRD-HI readouts will be correlated with Head CT results after each scan.
Baseline, at time of NIRD-HI testing administered
Diagnostic Performance - Time Detection of ICH
Baseline, at time of NIRD-HI testing administered
Diagnostic Performance - Operator Performance
Baseline, at time of NIRD-HI testing administered
Accuracy of evolution testing [first NIRD HI scan vs. second NIRD HI]
Baseline, at time of NIRD-HI testing administered
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Riley JD, Amyot F, Pohida T, Pursley R, Ardeshirpour Y, Kainerstorfer JM, Najafizadeh L, Chernomordik V, Smith P, Smirniotopoulos J, Wassermann EM, Gandjbakhche AH. A hematoma detector-a practical application of instrumental motion as signal in near infra-red imaging. Biomed Opt Express. 2012 Jan 1;3(1):192-205. doi: 10.1364/BOE.3.000192. Epub 2011 Dec 20.
Bell RS, Vo AH, Neal CJ, Tigno J, Roberts R, Mossop C, Dunne JR, Armonda RA. Military traumatic brain and spinal column injury: a 5-year study of the impact blast and other military grade weaponry on the central nervous system. J Trauma. 2009 Apr;66(4 Suppl):S104-11. doi: 10.1097/TA.0b013e31819d88c8.
Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. Report to Congress on traumatic brain injury in the United States: Epidemiology and rehabilitation. Atlanta (GA): Centers for Disease Control and Prevention; 2015
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 29, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 13, 2026
Record last verified: 2026-01
IPD data will not be shared
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Source: ClinicalTrials.gov.
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