N/A
N=672
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Head Trauma · Craniocerebral Injuries · Crushing Skull Injury · Head Injuries · Head Injuries, Multiple
Bottom Line
View on ClinicalTrials.gov: NCT04505293 ↗Enrolled (actual)
672
Serious AEs
—
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status — 158; 22; 126; 81 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- InfraScanner 2000™ (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status |
158; 22; 126; 81 | — |
| SECONDARY Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) |
136; 15; 126; 81 | — |
| SECONDARY Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) |
148; 17; 126; 81 | — |
| SECONDARY Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) |
47; 252; 41; 9; 2; 0 | — |
| SECONDARY Identify Reasons CT Not Performed |
— | — |
| SECONDARY Causes of Head Trauma as Identified Through the Medical Record |
179; 36; 24; 14; 12; 9 | — |
Summary
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
Eligibility Criteria
Inclusion Criteria
- Any patient who presents to MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda will be considered for this study.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04505293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.