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N/A Completed N=73

Rapid MRI for Acute Pediatric Head Trauma

Head Trauma · Image, Body
Source: ClinicalTrials.gov NCT03291964 ↗
Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives) — 70 Percentage of MRIs correctly identifying

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.

Outcome Measures

OutcomeResultp-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)

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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