Clinical Evaluation Of The I-Stat Tbi Test
Posted Date: Jul 13, 2021
- Investigator: Laura Ngwenya
- Specialties: Emergency Medicine, Neurosurgery
- Type of Study: Device
The proposed study encompasses a primary objective and a secondary objective. To meet these objectives, the study will enroll subjects with GCS scores of 3 to 15. The primary objective of this study is to determine the clinical performance of the i-STAT TBI test when it is used for the proposed intended use: to assist in determining the need for a CT scan in patients presenting with suspected mild traumatic brain injury who are 18 years of age or older, have a Glasgow Coma Scale score of 13-15 and present within 12 hours of injury. The clinical performance will be determined for both intended sample types, whole blood and plasma.
Patients Aged 18 & Older That Come Into The Ed Within 12 Hours Of Initial Head Injury. Gcs Scores 3-15
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