Rapid MRI for Acute Pediatric Head Trauma

NCT03291964 | Completed Results DMC

• 1 other identifier: 17254
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Trauma; Image, Body

Outcome Measures

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.

  within 6 hours from the initial head CT

Secondary Outcomes (2)

• Time From Order to Obtaining MRI

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

• Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)

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

Interventions

Rapid Brain MRI DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Results Point of Contact

• Title: David Sheridan Assistant Prof
• Organization: Oregon Health and Science university

sheridda@ohsu.edu

5034941691

Study Officials

• David Sheridan, MD MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine/Pediatrics

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: September 25, 2017
• Study Start: September 3, 2017
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)