The PIONEER Comparative Effectiveness Study - Project 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Comparing the Effectiveness of a Biomarker-plus-clinical Guidelines Algorithm Versus Clinical Guidelines Only for Safely Decreasing Brain Computed Tomography Utilization During Brain Injury Evaluations: The PIONEER Comparative Effectiveness Study

Conditions

Head Injury Trauma, Traumatic Brain Injury, Mild

Being tested

Clinical pathway 1: Guidelines plus biomarkers, Clinical guidelines only

Keywords

Emergency department, Struck by or against an object, traumatic brain injury, TBI, CT imaging, head CT, brain CT, biomarkers, clinical decision rule, implementation study, gfap, UCH-L1, glial fibrillary acidic protein, Ubiquitin Carboxy-terminal hydrolase L1

Medical subject headings

Brain Concussion, Emergencies, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Clinical pathway 1: Guidelines plus biomarkersDiagnostic 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 onlyDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The proportion of eligible emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging.

   Measured: Initial Emergency Department Visit (approximately 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Sep 2026
2. Study start1 Oct 2026 (estimated)
3. Primary completionJan 2029 (estimated)
4. Study completionJan 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Head Injury TraumaStudies of the same condition, open and under way.
• More trials run by University of MichiganThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.