The PIONEER Comparative Effectiveness Study - Project 2
Public ClinicalTrials.gov record NCT07829107. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07829107
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 3,000 participants
Conditions and interventions
Conditions
Interventions
- Clinical pathway 1: Guidelines plus biomarkers Diagnostic Test
- Clinical guidelines only Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
- Last update posted
- Sep 21, 2026
2026 – 2029
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA-Olive View Medical Center | Sylmar | California | 91342 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Henry Ford Macomb (HFM) | Clinton Township | Michigan | 48038 | — |
| Henry Ford Hospital (HFH) | Detroit | Michigan | 48202 | — |
| Adventist Health Portland (AHP) | Portland | Oregon | 97216 | — |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07829107, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2026 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07829107 live on ClinicalTrials.gov.