RecruitingNCT07829107ClinicalTrials.gov record

The PIONEER Comparative Effectiveness Study - Project 2

Head Injury Trauma · Traumatic Brain Injury, Mild

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 3000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion

Age ≥18 years at the time of the emergency department visit.
Presentation to a participating emergency department following a traumatic injury mechanism (motor vehicle collision, fall from height, assault, head injury/head trauma/head strike, struck by or against an object, facial injury or laceration, or other general trauma). Presentations may also include alcohol intoxication or syncope when associated with a suspected traumatic brain injury.
Evidence of potential head or brain injury, defined as (i) the head being struck by an object, (ii) the head striking a hard object or surface, (iii) exposure of the brain to significant acceleration/deceleration forces, or (iv) clinician documentation that the patient was evaluated for suspected traumatic brain injury.
Glasgow Coma Scale (GCS) score of 13-15 at presentation.
Presentation to the emergency department within 24 hours of injury.

Exclusion Criteria:

Planned computed tomography (CT) imaging of the maxillofacial bones, chest, abdomen, or pelvis during the ED encounter AND clinicians do not intend to avoid brain CT imaging even if the biomarker test is negative.
Current use of anticoagulant or antiplatelet therapy, including but not limited to: Warfarin, Factor Xa inhibitors (e.g., apixaban \[Eliquis\], rivaroxaban \[Xarelto\]), Clopidogrel, Ticagrelor.
Presentation \>24 hours after injury, due to the declining diagnostic sensitivity of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) beyond this time window.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Clinical Pathway 2: Clinical Guidelines Only

Clinical Guidelines Only (Canadian CT Head Rule)

Diagnostic Test: Clinical guidelines only

Clinical Pathway 1: Guidelines + Biomarkers

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

Clinical pathway 1: Guidelines plus biomarkers DIAGNOSTIC_TEST

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.

Clinical guidelines only DIAGNOSTIC_TEST

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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)