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CompletedNCT03291964Updated Jan 26, 2023Results posted

Rapid MRI for Acute Pediatric Head Trauma

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Ages
0 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head Trauma
  • Image, Body
03

Who can participate

Ages eligible
0 Years to 14 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All pediatric trauma patients being evaluated with a head CT for acute intracranial injury

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testRapid 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.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Time From Order to Obtaining MRI

    minutes

    Time frame: During initial ER stay within 3 hours from time of entry to the ER

  2. 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

06

Results

Posted Jan 26, 2023

Participant flow

Participant flow — Overall Study
MilestoneQuick Brain
Started73
Completed73
Not completed0

Outcome measures

PrimarySensitivity: 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
Reported as:
Number · Percentage of MRIs correctly identifying
Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)
Percentage of MRIs correctly identifyingQuick Brain
Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)70
SecondaryTime From Order to Obtaining MRI

minutes

Time frame:
During initial ER stay within 3 hours from time of entry to the ER

Results for this outcome have not been posted.

SecondaryNeed 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

Results for this outcome have not been posted.

Adverse events

Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Quick Brain0/73 (0%)0/73 (0%)0/73 (0%)

Baseline characteristics

children being evaluated in the ED for head trauma.

Age, Categorical
Age, Categorical(Participants)Quick Brain
<=18 years73
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Quick Brain
Mean4.0 (1 to 10)
Sex: Female, Male
Sex: Female, Male(Participants)Quick Brain
Female38
Male35
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Quick Brain
Hispanic or Latino0
Not Hispanic or Latino0
Unknown or Not Reported73
Region of Enrollment
Region of Enrollment(participants)Quick Brain
United States73
07

Study locations

1 site
  • OHSU
    Portland, Oregon 97239, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 19, 2017
  • Informed consent form · Jul 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03291964
Lead sponsor
Oregon Health and Science University
Responsible party
Dr. David Sheridan (Assistant Professor of Emergency Medicine/Pediatrics, Oregon Health and Science University) — Principal investigator
First posted
Sep 25, 2017
Start date
Sep 3, 2017
Primary completion
Aug 1, 2019
Completion
Dec 1, 2019
Results posted
Jan 26, 2023
Last update
Jan 26, 2023

Study contacts

David Sheridan, MD MCR
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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