Biomarkers + Guidelines for Traumatic Brain Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Frederick Korley, MD, PhD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for people who come to the emergency department with a suspected traumatic brain injury, such as concussion or head injury. There are no detailed inclusion or exclusion criteria listed, so it appears open to most patients being evaluated for these conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Data Collection
All six participating EDs contribute baseline data under usual care (clinical guidelines only)
Implementation
Transition to implementing the biomarker-guided algorithm at different sites
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of deciding if someone needs a brain CT scan after a head injury: using standard clinical guidelines alone versus using both guidelines and special blood tests (biomarkers) that detect signs of brain injury.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Clinical Guidelines Only (Canadian CT Head Rule)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
United States Department of Defense
Collaborator
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