Craniocerebral Trauma Clinical Trial
Official title:
The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury
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.
Status | Completed |
Enrollment | 3556 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Sheffield | National Institute for Health Research, United Kingdom |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Prevalence of ongoing symptoms relating to the head injury | Impaired activities of daily living (assessed by the EQ5D) | 18 months | No |
Secondary | Prevalence of ongoing symptoms relating to the head injury | Headache symptoms | 18 months | No |
Secondary | Prevalence of ongoing symptoms relating to the head injury | Impaired cognitive function (assessed by the Glasgow Outcome Scale) | 18 months | No |
Secondary | Identification of early predictors of adverse clinical outcome | Including clinical features and initial investigations which may be useful as a diagnostic tool. | 18 months | No |
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