Rapid MRI for Acute Pediatric Head Trauma

Head Trauma Clinical Trial

Official title:

QuickBrain MRI for Acute Pediatric Head Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291964
• Other study ID #: 17254
• Status: Completed
• Start date: September 3, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 1, 2019
• Est. primary completion date: August 1, 2019
• Gender: All
• Age group: 0 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Trauma
• Image, Body
• Wounds and Injuries

Intervention

Diagnostic Test:
• Rapid Brain MRI
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.

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 6 hours from the initial head CT
Secondary	Time From Order to Obtaining MRI	minutes	During initial ER stay within 3 hours from time of entry to the ER
Secondary	Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)	Number of patients requiring medication to obtain imaging	During initial ER stay within 3 hours from time of entry to the ER