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

8 juin 2026 mis à jour par: University of Chicago

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

270

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Subjects with confirmed PBI.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Building the first PBI Data Commons, Biorepository, and Imaging Repository
Délai: 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.
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quantitative biomarker analysis using validated laboratory assays conducted at Orlando Health and Mayo Clinic Laboratories.
Délai: 3 months
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.
3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2035

Achèvement de l'étude (Estimé)

31 décembre 2035

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

8 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IRB25-0888
  • Medical Technology Enterprise (Autre subvention/numéro de financement: Department of Defense)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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