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Completed

NCT Number: NCT02461498

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.

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Key information

Conditions

Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of ongoing symptoms relating to the head injury

    Time frame: 18 months

    Impaired activities of daily living (assessed by the EQ5D)

  2. Prevalence of ongoing symptoms relating to the head injury

    Time frame: 18 months

    Headache symptoms

  3. Prevalence of ongoing symptoms relating to the head injury

    Time frame: 18 months

    Impaired cognitive function (assessed by the Glasgow Outcome Scale)

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Sheffield

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 3, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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