Clinical trial NCT03291964: Rapid MRI for Acute Pediatric Head Trauma
Official title: QuickBrain MRI for Acute Pediatric Head Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Trauma
Image, Body
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 76
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric trauma patients being evaluated with a head CT for acute intracranial injury

Brief 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.

Detailed description: Initial retrospective study suggests that QbMRI has adequate sensitivity to detect acute ciTBIs in children. This preliminary study included all pediatric trauma patients presenting to OHSU from 2/2010 through 12/2013 who had both a head CT and QbMRI. The current standard of care in the pediatric ICU at OHSU is for patients admitted with an acute head injury to undergo routine QbMRI follow up to assess status of the injury rather than a repeat head CT. Our study team collected clinical data on these patients that included clinical interventions and then de-identified all head CT and QbMRI images for this cohort. The images were then independently reviewed by 2 neuroradiology fellows at OHSU (Please refer to Figure 1). The sensitivity of QbMRI to detect any radiographic injury was 85% (95% CI: 73, 93), but increased when evaluating clinically important TBIs to 100% (95% CI: 89, 100). The largest limitation of this study was the variable and often long time interval between acquisition of the head CT and QbMRI. The average length of time between the initial head CT and QbMRI was 27.5 hours with only 41% receiving both imaging tests within 12 hours of each other. Also, preliminary data was collected by retrospective review. As such, it is very promising that initial study had high sensitivity, but further prospective pilot data with a shorter interval between the index and reference test is needed to assess the discrepancy between the two types of lesions (radiographic vs clinically important) and feasibility of obtaining qbMRI in the setting of acute pediatric head trauma. While this study did not miss any clinically important TBIs, on further review of radiographic "missed lesions", the study pediatric neurosurgeon noted signs of a healing bleed. This may suggest that they were "missed" because they were healed rather than present and not seen. All patients that did not have a lesion identified on QbMRI did not require significant clinical interventions and only underwent periods of observation in the hospital. However, this raises the need for a prospective trial to obtain QbMRI imaging within the same time frame sequentially after the initial head CT.

Eligibility criteria: Inclusion Criteria:

1. The patient presents to the pediatric emergency department or trauma system at OHSU or is a trauma system transfer patient to OHSU
2. Age 0-14 years.
3. Being evaluated for a traumatic head injury and attending physician decides to obtain a head CT.
4. Clinically stable for additional testing: provider deems it safe to obtain a QbMRI in the ED without deep sedation

Exclusion Criteria:

1. Subject is from outside hospital and head CT was performed greater than 6 hours prior
2. Subject is from outside hospital and initial head CT is not in our imaging system for review
3. History of intracranial surgery
4. History of metallic implants making MRI contraindicated
5. Decompressive surgery prior to QbMRI

Primary outcomes:
measure: Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)
timeFrame: within 6 hours from the initial head CT
Secondary outcomes:
measure: Time From Order to Obtaining MRI
timeFrame: During initial ER stay within 3 hours from time of entry to the ER
measure: Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)
timeFrame: During initial ER stay within 3 hours from time of entry to the ER
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Sheridan, MD MCR
role: PRINCIPAL_INVESTIGATOR
References: