Clinical trial NCT07014748: SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine
Official title: SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Hemorrhage
Keywords: TBI
ICH
Intracranial hematoma
Ukraine
Trauma
NIRS
Near Infrared
Lead sponsor: InfraScan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: USARMY USAMRMC
First posted: 2025-06-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected combat-related head trauma

Brief summary: The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and K241389 approved higher laser power use to address dark skinned patients in 2024. This non randomized observational study aims to evaluate the utility of this device by evaluating its ability to provide decision support information to optimize care for patients with suspected traumatic intracranial hematomas. It is important to note that the intended use of the device is in accordance with its FDA approved indication. The intent is to generate actionable knowledge that along with standard clinical signs, facilitates the early detection of intracranial hemorrhage (ICH) in patients with suspected traumatic brain injury (TBI) in a combat setting. The ultimate goal is to modify and optimize international protocols for inexpensive, bedside, portable, and noninvasive detection of traumatic ICH in conflict zones across the globe.

This multicenter, prospective, observational, implementation science study will evaluate the field utility of the Infrascanner Model 2500 in an active combat setting using a pragmatic, sequential research design consisting of two phases-baseline phase and device phase. Using the current Ukrainian medical care system, patients with suspected TBIs will be monitored, and their outcomes will be tracked using standard-of-care practices (baseline phase). After the baseline data collection period is complete, an amendment to the protocol will be submitted to initiate the device phase. After training and upon approval, the Infrascanner device will be deployed to the facilities described above to provide health care providers with additional decision support, and the impact of its use will be compared to the baseline data. The outcome of interest is the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH. The investigators hypothesize that the use of the device will provide decision support to health care providers, decrease the time to traumatic ICH detection, thus enabling more expedient care.

This prospective study will include all patients with suspected combat-related head trauma identified by clinical signs of TBI, such as decreased GCS score, abnormal pupil exam, and/or asymmetrical motor exam, on admission to the clinical enrollment site (mobile hospital or regional clinical hospital) regardless of the presence of pharmacologic sedation. At the Vinnytsia hospital (Role 4), combat polytrauma preoperative patients will also be screened. Exclusion criteria include evidence of extensive scalp injury, including lacerations, avulsions, or abrasions that prevent proper placement of the Infrascanner device on a subject's head or prevent placement of the device in the specified locations.

During the baseline phase (Figure 1), 100 patients will be enrolled at stabilization points and the mobile/first-line hospital, 100 will be enrolled at the second-line hospital, and 100 will be enrolled at the third-line hospital. Thus, from a total of 300 subjects, baseline data on the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH and treatment and early outcomes will be collected.

Once the baseline phase is complete and the amendment for the device phase is approved, it will be initiated. During this device phase, the Infrascanner will be deployed to stabilization points and the three levels of care (mobile hospitals and regional clinical hospitals). Data collection will continue until 100 patients are enrolled in the device phase for the three levels of care. All data collection at the baseline and device phases will occur at the same locations, and the data elements will be identical, except for Infrascanner data collected during the device phase.

By comparing data from the baseline and device phase, the investigators will assess the utility of the device to provide decision support information to providers and potentially reduce time to definitive diagnosis by CT scan and thus treatment, as well as the association between Infrascanner use and early patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected combat-related head trauma identified by clinical signs of TBI on admission to the clinical enrollment site
* Clinical signs of TBI:

  * Decreased GCS score
  * Abnormal pupil exam
  * Asymmetrical motor exam
* The presence of pharmacologic sedation is not exclusion criteria.

Exclusion Criteria:

* Evidence of extensive scalp injury that prevent proper placement of the Infrascanner device on a subject's head or prevent placement of the device in the specified locations.
* Extensive scalp injury includes lacerations, avulsions, or abrasions

Primary outcomes:
measure: Time from admission to definitive diagnosis
timeFrame: From admission at each enrollment study location to a definitive CT scan diagnosis of intracranial hemorrhage (ICH), which is up to 24 hours from admission.
Secondary outcomes:
measure: Final Glasgow Coma Scale at discharge or transfer
timeFrame: From admission to the hospital until 3 days from admission
measure: Number of Brain-related complications
timeFrame: From admission to the hospital until 3 days from admission
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama in Birmingham
state: Alabama
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov of Dnipropetrovsk Regional Council
city: Kyiv
country: Ukraine
facility: Ukrainian Military
city: Vinnytsia
country: Ukraine
facility: Vinnytsia City Clinical Hospital named after M.I.Pirogov of Vinnitsya Regional Council
Study officials:
affiliation: Vinnytsia City Clinical Hospital named after M.I.Pirogov of Vinnitsya Regional Council
name: Dmytro Dmytriiev, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: