Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda

Not Applicable

Completed

• Conditions: Head Trauma; Crushing Skull Injury; Head Injury Major; Injury, Head; Head Injury; Head Injuries, Multiple; Head Trauma, Penetrating; Craniocerebral Injury; Head Trauma,Closed; Trauma, Head
• Interventions: Device: InfraScanner 2500™

• Registration Number: NCT06491173
• Lead Sponsor: Duke University

Brief Summary

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the portable near-infrared-based device (portable NIR-based device), the InfraScanner 2500™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) or Mayanja Memorial Hospital (MMH) who have sustained or who are suspected to have sustained head trauma.

Detailed Description

When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approaching the patient. While head trauma frequently results in impaired cognition and/or consciousness, and due to the urgency of these circumstances patients are often not accompanied by kin, whenever appropriate, the purpose of the research and the procedure will be explained in detail with all questions answered to the patient's and/or representative's satisfaction. Because patients who sustain head trauma injuries typically remain within the hospital for multiple days for monitoring and care, each participant may undergo multiple Computed Tomography (CT) scans over the course of his or her hospitalization, affording the opportunity of one to numerous measurements from each patient during his or her hospital stay.

Upon presentation to the casualty unit at MRRH or MMH and following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2500™. If permission is granted, the study team member sequentially measures the optical absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and occipital bilaterally). The device is engineered such that the light emitter and receiver are spaced 4 cm apart, allowing the light's intensity to be measured between adjacent light guides. This entire procedure, including greeting and scanning the patient should take \<10 minutes. Subsequent CT scan(s) the patient receives determines the number of potential data collections.

The patient and/or representative may refuse a scan during any encounter, and as such, the scan will not be done. For each patient scanned with the InfraScanner 2500™ they will be de-identified with a subject number, with age, sex, gender, skin color, hair color, hair thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT scan and near-infrared measurement. These data will be stored in de-identified form on the Research Electronic Data Capture (REDCap) database and/or Microsoft Excel on a secured network drive within the Department of Neurosurgery at Duke.

The collection period for each research subject concludes 30-days following his or her initial measurement with the InfraScanner 2500™, patient discharge, or patient death.

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-08
• Study Start: 2024-07-30
• Status Verified: 2024-08
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-30
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Any patient who presents to MRRH or MMH with suspected head trauma, who is able to, or who has a legally authorized representative who is able to consent in English, Swahili, or Luganda will be considered for this study.

Exclusion Criteria

• Patients for which wounds to their head are too large to properly use the InfraScanner 2500™ will be excluded from this study. Patients will also be excluded if hair cannot be appropriately parted to allow for the fiberoptic tips of the device to make direct contact with the scalp. Patients for whom it is not possible to obtain an Infrascan within 30 minutes of their CT imaging will also be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
InfraScanner 2500™	InfraScanner 2500™	All patients entered into the trial will undergo at least one cranial scanning using the InfraScanner 2500™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2500™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2500™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2500™ are positive consideration of further follow-up will be given on a case-by-case basis.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Detection of Intracranial hemorrhage (ICH) by the InfraScanner 2500™ Stratified by CT Positive and CT Negative Status	Within 30 minutes following CT scan	Precision of the InfraScanner 2500™ relative to CT scans in an African, LMIC (lower middle income country) population.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Detection of Intracranial hemorrhage (ICH) by the InfraScanner 2500™	Within 30 minutes following CT scan	Accuracy of the InfraScanner 2500™ in darker-skinned populations within LMICs.

Trial Locations

Locations (2)

Mayanja Memorial Hospital; 🇺🇬 Mbarara, Uganda

Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda