The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Study Overview
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Brief Summary
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Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing patients taking warfarin after a blunt head injury is variable with little research that supports the most appropriate way to manage these patients. The investigators aimed to undertake research in order to understand the range and frequency of outcomes following head injury in this group of patients and to develop robust clinical guidance for how they should be optimally managed in the future.

Detailed Description
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This prospective observational study aims to enrol patients taking warfarin that attend participating ED's (up to 33) in England and Scotland after blunt head injury. Over an 18-month period from Oct 2011, ED attendance data will be collected from each ED as well as information from patient questionnaires about the care the patient received and the status of their health 6-10 weeks after the injury. Patients who died due to their head injury, experienced surgery due to their injury, had a change identified on a CT scan or re-attended the ED with a clear head injury complication are defined as experiencing a poor outcome. Information such as the patients' conscious state (GCS), level of clotting in their blood (INR) and symptoms will be investigated as predictors of a poor outcome. A mathematical model will be used to estimate the most cost-effective strategy assuming published National Institute for Health and Care Excellence (NICE) thresholds for cost per quality adjusted life year (QALY).

Official Title
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The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Conditions
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Craniocerebral Trauma, Head Injuries, Closed

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16 years or older Blunt head trauma above the neck within 24 hours of ED attendance Prescribed warfarin Exclusion Criteria: Penetrating injuries to the head, for example knife wound.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of head injury complication in study cohort | Head injury complications defined as death or neurosurgery resulting from the initial injury, a clinically-significant CT scan finding or re-attendance to the ED with a significant head injury-related complication up to 10 weeks after the original attendance. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ongoing symptoms relating to the head injury | Impaired activities of daily living (assessed by the EQ5D) | 18 months | 
| Prevalence of ongoing symptoms relating to the head injury | Headache symptoms | 18 months | 
| Prevalence of ongoing symptoms relating to the head injury | Impaired cognitive function (assessed by the Glasgow Outcome Scale) | 18 months | 
| Identification of early predictors of adverse clinical outcome | Including clinical features and initial investigations which may be useful as a diagnostic tool. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Warfarin