Injury, Occupational Diseases, Poisoning Nervous System Diseases
Conditions
Interventions
PIONEER
Sponsors
United States Department of Defense
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for the study if they are: Age =18 years Evaluated for suspected TBI at a participating district hospital. TBI is defined according to the 2023 American Congress of Rehabilitation Medicine (ACRM) Diagnostic Criteria for TBI Can be enrolled within 24 hours of injury Clinicians recommend transfer to a regional hospital for brain CT imaging Written informed consent can be obtained either from the patient or from a legally authorized representative if the patient has a GCS of <15 or cognitive impairment. The ACRM Diagnostic Criteria for TBI is operationalized here as: following a biomechanically plausible mechanism of injury ((1) head being struck with an object; (2) head striking a hard object or surface; (3) brain undergoing an acceleration/deceleration movement without direct contact between the head and an object or surface; and/or (4) forces generated from a blast or explosion}), and meeting at least one of the following additional criteria: One or more clinical signs attributable to brain injury (Criterion 2, see below) A least 2 acute symptoms (Criterion 3, see below) and at least one clinical finding (Criterion 4, see below) attributable to brain injury and confounding factors such as intoxication do not fully account for the clinical signs (Criterion 2), acute symptoms (Criterion 3), and clinical examination. Criterion 2 - Clinical Signs: The injury event causes an acute physiological disruption of brain function, as manifested by one or more of the clinical signs listed below. Loss of consciousness immediately following injury (eg, no protective action taken on falling after impact or lying motionless and unresponsive). Alteration of mental status immediately following the injury (or upon regaining consciousness), evidenced by reduced responsiveness or inappropriate responses to external stimuli; slowness to respond to questions or instructions; agitated behavior; inability to follow two-part commands; or disorientation to time, p
Exclusion criteria
Exclusion criteria: Patients will be excluded if they meet any of the following criteria GCS<13 at enrollment a focal neurological exam On oral anticoagulation medications since they need close monitoring and a higher echelon of care; Evidence of multisystem trauma requiring a CT of the chest or abdomen, or maxillofacial bones; High risk of loss to follow-up within seven days following injury; Brain CT scan cannot be performed within 24 hours of GFAP and UCH-L1 measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High risk for clinical and/or radiographic deterioration, defined as Brain Injury Guideline (BIG) Class 2 or 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical or radiographic progression or neurosurgical intervention within seven days of injury. Radiographic progression is defined as an increase in the size of a previous intracranial hemorrhage or the development of a new intracranial hemorrhage. Clinical progression is defined as the occurrence of new abnormal neurologic examinations, such as focal neurologic deficits, abnormal pupillary responses, and a 2-point or greater decrease in GCS for more than 2 hours. Neurosurgical intervention is defined as craniotomy, craniectomy, and/or ICP monitor/EVD placement ;Clinically significant traumatic intracranial lesion seen on CT.; Intervention Characteristics Perceived ease of use of the devices; Perceived usefulness in clinical decision-making; Trust in the technology and diagnostic accuracy; Compatibility with existing clinical practices Inner Setting Organizational readiness and support for adoption; Impact on workflow efficiency or disruption; Availability of internal resources (e.g., staffing, training capacity, space, power supply) Outer Setting Alignment with community needs and expectations; Influence of external policies or funding structures; Cultural attitudes toward biomedical devices and testing Characteristics of Individuals (Patients and Providers) Attitudes and beliefs about advanced diagnostics; Knowledge and understanding of how the tools work; Level of familiarity with similar technologies; Perceived comfort and privacy concerns Process and Feasibility Willingness to adopt and sustain the use of the tools; Barriers and facilitators to integration in real-world low-resource settings; Suggested modifications to improve acceptability or fit | — |
Countries
Ghana
Contacts
Public ContactDaniel Osei Kwame
Consultant Emergency Physician Komfo Anokye Teaching Hospital
Outcome results
None listed