N/A
N=431
A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection
TBI (Traumatic Brain Injury)
Bottom Line
View on ClinicalTrials.gov: NCT00576147 ↗Enrolled (actual)
431
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: 1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. — 44; 25; 244; 6 Number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Infrascanner (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- InfraScan, Inc.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. |
44; 25; 244; 6 | — |
Summary
The purposes of this study are:
1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma.
2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers
Eligibility Criteria
Inclusion Criteria
- Undergoing a CT scan within 12 hours of their head injury. The criteria for obtaining a CT scan will be based on the standard of care, but generally all patients with a moderate or severe head injury will receive a CT scan on admission to the hospital, and only patients who undergo a CT will be enrolled into the study. The non-contrast CT will be performed according to standard methods.
Exclusion Criteria
- 12 hours or more since injury.
- Massive scalp lacerations, avulsions, and hematomas The limitation to injury within 12 hours is necessary because as hematoma blood is metabolized, the absorbance characteristics change.
Data sourced from ClinicalTrials.gov (NCT00576147). 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.