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Brain Injuries, AcuteBRIDGE-USNCT07636213

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

An observational study of Brain Injuries, Acute and Brain Trauma, run by University of Chicago at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Blood Sample Collection
How many people
270 participants
Where
1 siteUnited States
Study dates
1 Jul 2026to 31 Dec 2035
How long will I take part?
7 Days
Phase
Observational

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects with confirmed PBI.

Who may be able to join

  • Age: Subjects aged 16 years and older
  • Injury Type/Evidence: Patients with a confirmed PBI as demonstrated by head imaging or physical exam (evidence of dural penetration by a projectile)
  • Timeframe: Patients must be enrolled within 8 hours of injury

Who cannot join

  • 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:
  • Dead on Arrival (DOA): Patients who receive CPR with no return of pulse
  • Non-penetrating injury: Patients with head injuries that do not include dural penetration
  • Polytrauma: Patients with penetrating or blunt injuries to other parts of the body
  • Known or suspected pregnancy
  • Known or suspected prisoner

Trial locations and contacts

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

United States1 site
  • The University of Chicago

    Chicago, Illinois, 60637

    Hugh Flynn, 773-834-9627, Hugh.Flynn@bsd.uchicago.edu

    Hugh Flynn, Hugh.Flynn@bsd.uchicago.edu

Other trials in United States

About this study

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.

Read the detailed description

Penetrating brain injury (PBI) is one of the most devastating and understudied forms of traumatic brain injury (TBI), characterized by the violation of the skull and brain parenchyma by foreign objects such as bullets or shrapnel. Unlike blunt TBI, PBI involves unique mechanical and secondary injury patterns, including direct tissue destruction, vascular damage, hemorrhage, cavitation, and axonal shearing. These injuries often lead to severe disability or death, particularly in military and civilian populations exposed to ballistic trauma. Despite the increasing burden of firearm-related PBI in civilian trauma centers and the operational relevance in military settings, there remains a significant lack of structured data, standardized terminology, and biological understanding to guide prognostication or treatment decisions. This knowledge gap has fostered therapeutic nihilism, resulting in high rates of early withdrawal of life-sustaining therapies and a lack of targeted clinical pathways for these patients.

Emerging biomarker research in blunt TBI has identified several promising molecular indicators that reflect different aspects of brain injury. These include S100 calcium-binding protein B (S100B), glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), and neurofilament light chain (NFL), which are associated with glial activation, neuronal injury, and axonal damage, respectively. Elevated levels of GFAP and UCH-L1, for example, have been correlated with injury severity and poor outcomes in both civilian and military TBI populations, while NFL has shown potential as a predictor of long-term cognitive deficits. However, biomarker data specific to PBI is extremely limited. The distinct mechanical forces and injury patterns of PBI suggest that biomarker profiles may differ significantly from those seen in blunt trauma, highlighting the need for focused investigation. The temporal profiles of biomarkers have been assessed in blunt TBI but not in PBI. Advancing biomarker discovery in PBI could help identify patients at risk of poor outcomes, support early clinical decision-making, and differentiate PBI from overlapping conditions.

Beyond molecular markers, imaging plays a critical role in the diagnosis and management of PBI. High-resolution structural imaging, including computed tomography (CT) and advanced magnetic resonance imaging (MRI) techniques such as diffusion tensor imaging (DTI), provides critical insights into the extent of parenchymal damage, vascular injury, and axonal disruption. However, imaging access is often limited in prehospital or austere environments, especially in military settings. A combined approach leveraging clinical data, biomarkers, and imaging holds promise for improving the characterization of PBI and guiding treatment decisions across care environments.

The study's integrated approach 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.

Being tested
Blood Sample Collection
Medical subject headings
Brain Injuries, Brain Injuries, Traumatic, Head Injuries, Penetrating

What participants receive

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

  • Blood Sample CollectionOther

    Subjects with confirmed Penetrating Brain Injury (PBI) will be enrolled upon arrival to each site and have blood samples collected at five timepoints by nurses/phlebotomists/approved research personnel.

    As soon as possible after injury, preferably within 4 hours of injury, but must be obtained within 8 hours of injury.

What is being measured

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

  1. Building the first PBI Data Commons, Biorepository, and Imaging Repository

    The primary objective of this prospective study is to build the first comprehensive PBI Data Commons, Biorepository, and Imaging Repository. Clinical data, biospecimens, and imaging from subjects with PBI will be prospectively collected and analyzed across multiple sites, which will then be used to build these resources.

    Measured: 3 months

Secondary outcomes (1)
  1. Quantitative biomarker analysis using validated laboratory assays conducted at Orlando Health and Mayo Clinic Laboratories.

    Biospecimens will undergo biomarker analysis. This will provide another critical layer of information in the repositories for future studies aiming to improve rapid detection, diagnosis, prognostication, and outcome for casualties with PBI.

    Measured: 3 months

Timeline

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

  1. First posted9 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2035 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
270 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07636213
Sponsor's protocol ID
IRB25-0888
Other IDs
Medical Technology Enterprise
Acronym
BRIDGE-US
Status last verified
Jun 2026
First submitted
7 May 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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