Clinical Trial: The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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 Summary: 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).
Sponsor: University of Sheffield

Current Primary Outcome: Rate of head injury complication in study cohort [ Time Frame: 18 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Sheffield

Dates:
Date Received: May 27, 2015
Date Started: July 2011
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015