Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
|ClinicalTrials.gov Identifier: NCT01430988|
Recruitment Status : Terminated (The trial was terminated prematurely following a suspected data processing concern in the study device. The concern did not pose a patient safety issue.)
First Posted : September 9, 2011
Last Update Posted : May 3, 2012
|Condition or disease|
|Brain Injuries Craniocerebral Trauma|
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.
|Study Type :||Observational|
|Actual Enrollment :||318 participants|
|Observational Model:||Case Control|
|Official Title:||An Observational Clinical Study of the BrainScope® Ahead™ M-100 Hand Held Electroencephalogram in Emergency Department Patients With Head Injury (B-AHEAD UK Trial)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Head Injured Group
Subjects who are suspected of a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury, as a result of insult to the head from an external force, e.g., the head being struck by an object, the head striking an object, the head being exposed to forces generated from a blast or explosion, and/or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study
Normal Control Group
A normal control group will be recruited for comparison and will consist of Emergency Department patients who have sustained an injury but do not exhibit any trauma above the clavicle and no history of Road Traffic Accident requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope.
Head Injured Control Group
A 'head injured' control group will be recruited and will consist of Emergency Department patients who are suspected or who have sustained a head injury but do not report or manifest symptoms, e.g. facial lacerations and/or whiplash.
- Structural Injury Assessment [ Time Frame: Within 24 hours of head injury ]
There are four co-primary endpoints in this study: two sets of sensitivity and specificity to divide the data into three classes.
Using a BrainScope classification algorithm, the Ahead M100 will identify subjects showing sensitivities among 3 classes: Green-normal, nonhead injured controls,Yellow-head injured subjects who do not exhibit brain electrical activity that is consistent with a structural brain injury observable on CT or for whom CT was not deemed necessary,Red-head injured subjects who exhibit brain electrical activity consistent with a structural brain injury observable by CT.
- Functional Injury Assessment [ Time Frame: Within 24 hours of head injury ]There are two co-secondary endpoints for the secondary objective, the sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on a clinical charter used as the assessment of truth.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430988
|Royal London Hospital|
|Whitechapel, London, United Kingdom, E1 1BB|
|Salford Royal Hospital|
|Salford, Manchester, United Kingdom, M6 8HD|
|Cambridge, United Kingdom, CB2 0QQ|
|Principal Investigator:||Rupert Pearse, MD||Royal London Hospital, Barts and The London School of Medicine and Dentistry|