Summary of Study #3

A prospective, multi-center, observational study was conducted to evaluate the clinical performance of the i-STAT TBI cartridge in classifying intended use population subjects with suspected mild TBI for the likely absence of acute intracranial lesions visualized by a head CT scan. Venous whole blood specimens were collected in K2EDTA within 24 hours of the head injury.4

- Inclusion/Exclusion Criteria: Adults ≥18 years, presenting to Emergency Department with non-penetrating TBI and GCS 13-15, who had a head CT ordered as part of their standard of care, with blood test within 24 hours of injury at 20 Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI)
- The study population (n=970) had a median age of 46.0 years and ranged from 18 to 97 years. Over half (64.0%) were male and 68.6% were white and 17.7% were African American.
- A majority had a GCS of 15 (78.6%) and about two thirds had Loss of Consciousness (69.6%), Alteration of Consciousness (72.1%), visible trauma above the clavicle (65.6%) and post-traumatic amnesia (62.4%).
- The median time between injury and blood draw was 8.1 hours with a range of 1.5 to 24 hours.