N/A
N=73
Rapid MRI for Acute Pediatric Head Trauma
Head Trauma · Image, Body
Bottom Line
View on ClinicalTrials.gov: NCT03291964 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives) — 70 Percentage of MRIs correctly identifying
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rapid Brain MRI (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives) |
70 | — |
| SECONDARY Time From Order to Obtaining MRI |
— | — |
| SECONDARY Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication) |
— | — |
Summary
Pediatric head trauma is a leading cause of morbidity and mortality for children/adolescents. The current standard of care regarding imaging modality when concerned for an acute head injury is CT. This exposes children to radiation that may predispose to future malignancy. Rapid MRI is a test that eliminates radiation and has expanded uses in multiple other areas. This study is evaluating it for pediatric acute head trauma.
Eligibility Criteria
Inclusion Criteria
- The patient presents to the pediatric emergency department or trauma system at OHSU or is a trauma system transfer patient to OHSU
- Age 0-14 years.
- Being evaluated for a traumatic head injury and attending physician decides to obtain a head CT.
- Clinically stable for additional testing: provider deems it safe to obtain a QbMRI in the ED without deep sedation
Exclusion Criteria
- Subject is from outside hospital and head CT was performed greater than 6 hours prior
- Subject is from outside hospital and initial head CT is not in our imaging system for review
- History of intracranial surgery
- History of metallic implants making MRI contraindicated
- Decompressive surgery prior to QbMRI
Data sourced from ClinicalTrials.gov (NCT03291964). 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.