An observational study in Head Trauma and Image, Body, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 0 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Oregon Health and Science University · Observational
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.
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.
All pediatric trauma patients being evaluated with a head CT for acute intracranial injury
Exclusion Criteria:
Children undergoing head CT for evaluation of acute head injury will also undergo rapid brain MRI with GRE sequence that is specific for blood. Their clinical care will not change at all based on the MRI.
Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)
Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury. Sensitivity was calculated as the number of true positives divided by "true positive plus false negative". True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.
Time frame: within 6 hours from the initial head CT
Time From Order to Obtaining MRI
minutes
Time frame: During initial ER stay within 3 hours from time of entry to the ER
Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)
Number of patients requiring medication to obtain imaging
Time frame: During initial ER stay within 3 hours from time of entry to the ER
| Milestone | Quick Brain |
|---|---|
| Started | 73 |
| Completed | 73 |
| Not completed | 0 |
Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury. Sensitivity was calculated as the number of true positives divided by "true positive plus false negative". True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.
| Percentage of MRIs correctly identifying | Quick Brain |
|---|---|
| Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives) | 70 |
minutes
Results for this outcome have not been posted.
Number of patients requiring medication to obtain imaging
Results for this outcome have not been posted.
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quick Brain | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
children being evaluated in the ED for head trauma.
| Age, Categorical(Participants) | Quick Brain |
|---|---|
| <=18 years | 73 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Quick Brain |
|---|---|
| Mean | 4.0 (1 to 10) |
| Sex: Female, Male(Participants) | Quick Brain |
|---|---|
| Female | 38 |
| Male | 35 |
| Ethnicity (NIH/OMB)(Participants) | Quick Brain |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 73 |
| Region of Enrollment(participants) | Quick Brain |
|---|---|
| United States | 73 |
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Oregon Health and Science University