Trial Outcomes & Findings for Rapid MRI for Acute Pediatric Head Trauma (NCT NCT03291964)
NCT ID: NCT03291964
Last Updated: 2023-01-26
Results Overview
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.
COMPLETED
76 participants
within 6 hours from the initial head CT
2023-01-26
Participant Flow
Participant milestones
| Measure |
Quick Brain
Pediatric head trauma patients
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid MRI for Acute Pediatric Head Trauma
Baseline characteristics by cohort
| Measure |
Quick Brain
n=73 Participants
Pediatric head trauma patients
|
|---|---|
|
Age, Categorical
<=18 years
|
73 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
4.0 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: within 6 hours from the initial head CTSensitivity 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.
Outcome measures
| Measure |
Quick Brain
n=73 Participants
Pediatric head trauma patients
|
|---|---|
|
Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)
|
70 Percentage of MRIs correctly identifying
|
SECONDARY outcome
Timeframe: During initial ER stay within 3 hours from time of entry to the ERminutes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During initial ER stay within 3 hours from time of entry to the ERNumber of patients requiring medication to obtain imaging
Outcome measures
Outcome data not reported
Adverse Events
Quick Brain
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Sheridan Assistant Prof
Oregon Health and Science university
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place