NCT04171960

Clinical Evaluation of the i-STAT TBI Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,106 (actual)
• Sponsor: Abbott Point of Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draw	Venous whole blood collection within 12 hours and 12-24 hours following injury.
OTHER	Outcome assessments	Administered at baseline.

Timeline

• Start date: 2020-07-31
• Primary completion: 2023-06-26
• Completion: 2023-11-29
• First posted: 2019-11-21
• Last updated: 2024-09-19

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study