Traumatic Brain Injury
Conditions
Keywords
i-STAT, Traumatic Brain Injury, Biomarkers
Brief summary
The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI). Patients will be asked to provide a blood sample.
Detailed description
The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older. The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
Interventions
DIAGNOSTIC_TESTBlood draw
Venous whole blood collection within 12 hours and 12-24 hours following injury.
OTHEROutcome assessments
Administered at baseline.
Sponsors
United States Department of Defense
University of California, San Francisco
Abbott Point of Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Acute Blood Biomarker Branch Subject Inclusion Criteria: 1. 18 years of age or older. 2. Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB). 3. Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury. 4. Subject has a CT scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head CT scan sent from the originating facility. 5. As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following. 1. Any period of loss of consciousness 2. Any loss of memory for events immediately before or after the injury 3. Any alteration of mental state at the time of the injury 4. Focal neurological deficits that may or may not be transient Acute Blood Biomarker Branch Subject
Exclusion criteria
. 1. Previous enrollment in this study 2. Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device) 3. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke 4. Time of injury is unknown and cannot be estimated 5. Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association \[ASIA\] score of C or worse) at the enrolling facility 6. Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge 7. Prisoners or patients in custody 8. Patients on psychiatric hold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings. | Within 24 Hours of Traumatic Brain Injury (TBI) | Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings (+/-) for intra-cranial lesions for each subject. |
| Clinical performance measurement of the i-STAT TBI Test. | Within 24 hours of Traumatic Brain Injury (TBI) | Clinical performance metrics included, clinical sensitivity, clinical specificity, negative predictive value (NPV), positive predictive value (PPV), adjusted negative predictive value (adj. NPV) calculated to a 6% CT positive prevalence rate, negative likelihood ratio (neg. LR) and positive likelihood ratio (pos. LR). |
Countries
United States
Outcome results
None listed