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Rapid MRI for Acute Pediatric Head Trauma

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ClinicalTrials.gov Identifier: NCT03291964
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. David Sheridan, Oregon Health and Science University

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.

Condition or disease Intervention/treatment
Head Trauma Image, Body Diagnostic Test: Rapid Brain MRI

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: QuickBrain MRI for Acute Pediatric Head Trauma
Actual Study Start Date : September 3, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Sensitivity-Specificity [ Time Frame: within 6 hours from the initial head CT ]
    Sensitivity-Specificity of Rapid MRI for detection of an intracranial injury


Secondary Outcome Measures :
  1. Time from Order to obtaining MRI [ Time Frame: During initial ER stay within 3 hours from time of entry to the ER ]
    minutes

  2. Need for anxiolysis medication (defined as benzodiazepenes for imaging indication) [ Time Frame: During initial ER stay within 3 hours from time of entry to the ER ]
    Number of patients requiring medication to obtain imaging



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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All pediatric trauma patients being evaluated with a head CT for acute intracranial injury
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291964


Contacts
Contact: David Sheridan, MD MCR 5034941691 sheridda@ohsu.edu

Locations
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: David C Sheridan, MD    503-494-1691    sheridda@Ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: David Sheridan, MD MCR Oregon Health and Science University

Responsible Party: Dr. David Sheridan, Assistant Professor of Emergency Medicine/Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03291964     History of Changes
Other Study ID Numbers: 17254
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases