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Not Yet Recruiting NCT07636213

BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence

Conditions: Brain Injuries, Acute, Brain Trauma, Penetrating Head Injury, Traumatic Brain Injury

Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Enrollment: 270
Sponsor: University of Chicago

Location: The University of Chicago Chicago Illinois

Summary

The purpose of this research study is to prospectively collect biospecimens, imaging, and clinical data from patients with penetrating brain injuries across high-volume PBI sites in the US (including UChicago). Biospecimens will undergo biomarker analysis - biomarker data specific to PBI is extremely limited, and could provide critical insight to outcome identification and clinical decision making. This data will be used to build the first comprehensive PBI Data Commons, biorepository, and imaging repository which will create the infrastructure necessary to close critical knowledge gaps, advance biomarker discovery specific to PBI, and provide the foundation for future research aimed at improving prognostication and treatment for patients with this devastating injury.

Eligibility Criteria

Inclusion Criteria: 1. Age: Subjects aged 16 years and older 2. Injury Type/Evidence: Patients with a confirmed PBI as demonstrated by head imaging or physical exam (evidence of dural penetration by a projectile) 3. Timeframe: Patients must be enrolled within 8 hours of injury Exclusion Criteria: No subjects will be excluded based on gender or ethnicity for this study. Subjects under the age of 16 will be excluded. These subjects differ significantly in terms of neurodevelopment, physiology, and trauma response, which introduces heterogeneity that could confound study results. Additionally, pediatric PBI has distinct etiologies, treatment pathways, and prognostic indicators compared to adult PBI (note that age 16 and up are treated medically as adults). FULL EXCLUSION CRITERIA: 1. Dead on Arrival (DOA): Patients who receive CPR with no return of pulse 2. Non-penetrating injury: Patients with head injuries that do not include dural penetration 3. Polytrauma: Patients with penetrating or blunt injuries to other parts of the body 4. Known or suspected pregnancy 5. Known or suspected prisoner

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07636213). StuddyBuddy aggregates publicly available trial information.