An interventional study of Clinical pathway 1: Guidelines plus biomarkers and Clinical guidelines only in Head Injury Trauma and Traumatic Brain Injury, Mild, sponsored by University of Michigan. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
This is a pragmatic, open-label, multicenter, stepped-wedge, Type II hybrid effectiveness-implementation study. It is designed to evaluate both the comparative effectiveness and implementation feasibility of a biomarker-plus-clinical guidelines algorithm to reduce low-value brain computed tomography (CT) use in emergency department (ED) patients evaluated for suspected traumatic brain injury (TBI). The biomarkers are Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1), two brain-injury proteins cleared by the FDA to support brain CT imaging decisions after trauma. All six participating EDs will contribute baseline data for the first 6 months under usual care (clinical guidelines only). Beginning in month 7, two sites will transition to implementing the biomarker-guided algorithm. At month 13, two additional sites will implement the biomarker-guided approach, and the final two sites will transition at month 19. By the end of the 24-month rollout period, all sites will have implemented the biomarker-guided pathway.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Clinical Guidelines Only (Canadian CT Head Rule)
Diagnostic Test: Clinical guidelines only
Canadian CT Head Rule plus whole blood Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-Terminal Hydrolase L1 (UCH-L1) measurement using the i-STAT.
Diagnostic Test: Clinical pathway 1: Guidelines plus biomarkers
Patients will be managed using an algorithm that integrates the Canadian CT Head Rule (CCHR) with i-STAT whole-blood GFAP and UCH-L1 testing. Patients who meet CCHR criteria for CT imaging and those whose CT imaging decision-making is not covered by CCHR (e.g., no loss of consciousness or amnesia) will receive i-STAT testing. Sites will be assigned to one of three implementation waves, with two sites transitioning to the Guidelines + Biomarkers phase every six months. Prior to their assigned transition, sites will continue to use guidelines alone. Once a site transitions to the Guidelines + Biomarkers phase, the integrated biomarker-guided algorithm will become the standard-of-care protocol at that site for eligible patients and will remain the standard of care for the remainder of the study.
During the baseline phase, sites will rely solely on established clinical guidelines to guide brain CT utilization in patients with suspected TBI. Specifically, providers will apply the Canadian CT Head Rule, a validated decision instrument that identifies patients at high risk for clinically important brain injury who require CT imaging. All sites will begin in this Guidelines-Only baseline phase and will continue using this approach until their assigned transition to the Guidelines + Biomarkers phase. Sites will transition in three waves, with two sites transitioning every six months.
The proportion of eligible emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging.
Time frame: Initial Emergency Department Visit (approximately 24 hours)
Proportion of eligible ED patients with suspected TBI who receive brain CT imaging and have a clinically significant traumatic lesion.
Time frame: Initial Emergency Department Visit (approximately 24 hours)
Incidence of clinically significant missed traumatic intracranial injury diagnosed within 7 days of the index ED visit
Time frame: Within 7 days of the index/initial ED visit
Incidence of neurosurgical interventions within 7 days of the index ED visit, without a new traumatic event.
Time frame: Within 7 days of the index/initial ED visit
ED length of stay
This will be measured in minutes.
Time frame: Initial Emergency Department Visit (approximately 24 hours)
Initial and sustained provider adherence at 6 and 24 months post-implementation
Time frame: 6 and 24 months post-implementation
Provider acceptability and feedback
Providers will answer 17 questions regarding the implementation of the biomarker-guided algorithm and acceptability. Information from this will be summarized.
Time frame: During implementation phase (months 9-32)
Provider trust in biomarker-guided CT decision making as measured by the proportion of biomarker-negative patients who don't get a CT
Time frame: During implementation phase (months 9-32)
30-day ED revisits and hospitalizations
Time frame: 30 days following Initial Emergency Department Visit
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jan 2029, 27 months after the start.
Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 27 months is close to that.
Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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