Prospective implementation of novel evidence-based biomarkers for evaluating traumatic brain injury (the pioneer studies)

The Defense Health Agency (DHA) awarded the Regents of the University of Michigan $6.85 million under the Military Medical Research and Development program (CFDA 12.420) on September 30, 2025, to conduct the PIONEER (Prospective Implementation of Novel Evidence-Based Biomarkers for Evaluating Traumatic Brain Injury) Studies through September 29, 2029. The project delivers a multi-site clinical research program evaluating innovative blood-based and portable biomarkers for traumatic brain injury (TBI) diagnosis and classification in emergency department settings. The research encompasses four integrated projects conducted across multiple clinical sites, including prospective patient enrollment, biomarker measurement using Abbott iSTAT multiplex immunoassay and Infrascanner assessments, clinical data collection, and 30-day patient follow-up to validate biomarker utility in TBI evaluation. University of Michigan serves as the prime recipient and program coordinator, with leadership providing overall study direction and coordination across sites.

The project engages six sub-awardees delivering specialized research and clinical infrastructure: Komfo Anokye Teaching Hospital (Ghana) will enroll 400 study participants and conduct onsite biomarker testing and clinical assessments; RAND Corporation provides qualitative research leadership through hospital leader and clinician interviews (approximately 40 individual and group interviews) and develops peer-reviewed publications analyzing implementation science barriers and facilitators; Henry Ford Health System, Oregon Health & Science University, and The Medical College of Wisconsin contribute emergency medicine research expertise, site coordination, implementation oversight, and data management; and US Acute Care Solutions (through USACS Management Group) provides regulatory oversight and clinical leadership at study sites. Together, these institutions deliver a prospective, evidence-generation platform designed to advance TBI clinical care protocols through implementation-tested biomarker-guided diagnostic and treatment pathways in diverse emergency care settings.