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.
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
- Conditions the study is for
- Brain Injuries, Acute, Brain Trauma, Penetrating Head Injury
- 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
- Are there results?
- Not yet: the study is under way
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
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.
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)
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.
- First posted9 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, AcuteStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence
- ClinicalTrials.gov ID
- NCT07636213
- Acronym / sponsor ID
- BRIDGE-US / IRB25-0888
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with confirmed PBI.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionSubjects 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. | Other | – |
Primary outcome
Building the first PBI Data Commons, Biorepository, and Imaging Repository
Time frame: 3 months
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.
1 secondary outcome
Quantitative biomarker analysis using validated laboratory assays conducted at Orlando Health and Mayo Clinic Laboratories.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Acute and Brain Trauma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugh Flynn (773-834-9627, Hugh.Flynn@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Building the first PBI Data Commons, Biorepository, and Imaging Repository (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.