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
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Among 95 studies in Craniocerebral Trauma with a site in United States — 12 open to participants now, 17 under way, none of them phase 3. Craniocerebral Trauma · United States.
Among the 95 studies in Craniocerebral Trauma with a site in United States, this one is the 24th largest by enrollment of the 33 observational ones that give a count, is one of 7 that started in 2017, is one of 33 observational ones, and was the 53rd registered.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
Browse Craniocerebral Trauma studies →12 of the 95 studies in Craniocerebral Trauma with a site in United States are open now. Recruiting first, the newest first:
Northern California Institute of Research and Education · Sites in United States
Ages 50–89
Wake Forest University Health Sciences · Sites in United States
Ages up to 18
New York Institute of Technology · Sites in United States
Ages 18–50 · Healthy volunteers
University of California, Davis · Sites in United States
Ages 11–17
VA Office of Research and Development · Sites in United States
Ages 22–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Craniocerebral Trauma studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.
This study: 0 Years to 14 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 4 · Phase 3 4 · Phase 4 2
First in 1983; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 76 is below the median of 180 across 111 observational studies indexed under Craniocerebral Trauma.
Median enrollment 94 across the 61 interventional studies, 192 across the 33 observational. Of the 69 that completed or were terminated, 17 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 95 have an industry lead sponsor. The 10 most frequent:
Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Oregon Health and Science University has 1 study filed under Craniocerebral Trauma — fewer than ten, so there is no comparison to draw.
3 of the studies in Craniocerebral Trauma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06632587Thomas Jefferson UniversityTiming Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes | 2026-12-01 |
| NCT06697808Wake Forest University Health SciencesCranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics | 2027-04 |
| NCT05663034Johns Hopkins UniversityCBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms | 2027-06 |
Add all 3 to your calendar (.ics) → With an account.
Among the 95 studies in Craniocerebral Trauma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
All pediatric trauma patients being evaluated with a head CT for acute intracranial injury
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time From Order to Obtaining MRI
minutes
Time frame: During initial ER stay within 3 hours from time of entry to the ER
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
| Milestone | Quick Brain |
|---|---|
| Started | 73 |
| Completed | 73 |
| Not completed | 0 |
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.
| Percentage of MRIs correctly identifying | Quick Brain |
|---|---|
| Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives) | 70 |
minutes
Results for this outcome have not been posted.
Number of patients requiring medication to obtain imaging
Results for this outcome have not been posted.
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quick Brain | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
children being evaluated in the ED for head trauma.
| Age, Categorical(Participants) | Quick Brain |
|---|---|
| <=18 years | 73 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Quick Brain |
|---|---|
| Mean | 4.0 (1 to 10) |
| Sex: Female, Male(Participants) | Quick Brain |
|---|---|
| Female | 38 |
| Male | 35 |
| Ethnicity (NIH/OMB)(Participants) | Quick Brain |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 73 |
| Region of Enrollment(participants) | Quick Brain |
|---|---|
| United States | 73 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Aug 2019, 22 months.
Results were first posted in Jan 2023, 3 years 5 months after primary completion.
Of 43 non-industry observational studies under Craniocerebral Trauma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's 22 months is below that.
Counting every sponsor, half of 43 studies reached it within 32 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University →