NCT01430988

Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury

An Observational Clinical Study of the BrainScope® Ahead™ M-100 Hand Held Electroencephalogram in Emergency Department Patients With Head Injury (B-AHEAD UK Trial)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 318 (actual)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the current study is proposed to prospectively assess how accurately the BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.

Detailed description

One million patients attend Emergency Departments (ED) with head injuries each year in the United Kingdom (UK) and Ireland. 150,000 of these patients will need hospital admission and one study estimates an incidence of 45-48% moderate or severe disability in those surviving admission. Although the incidence of head injury is high, the incidence of death from head injury is low. Therefore ED's are required to see a large number of patients with a minor/mild head injury, and identify the very small number of these that will go on to have serious complications. The challenge to the emergency medicine clinician is identifying which patients with a head injury have an important brain injury that requires further attention and which patients can be safely sent home. The standard for determining an important brain injury is the result on the Computerised Tomography (CT) scan of the head. CT scanning is nonportable and exposes individuals to high radiation levels. The study medical device is a portable, point of care, noninvasive and non radiation-emitting medical device designed to assist clinicians in early identification, staging, and optimisation of treatment for patients who are head injured.

Conditions

• Brain Injuries
• Craniocerebral Trauma

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-09-09
• Last updated: 2012-05-03

Locations

3 sites across 1 country: United Kingdom