Clinical trial NCT02461498: The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury
Official title: The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniocerebral Trauma
Head Injuries, Closed
Keywords: Warfarin
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2015-06-03
Enrollment: 3556
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who attend participating emergency departments (ED) with a head injury and also prescribed warfarin

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 description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of head injury complication in study cohort
timeFrame: 18 months
Secondary outcomes:
measure: Prevalence of ongoing symptoms relating to the head injury
timeFrame: 18 months
measure: Prevalence of ongoing symptoms relating to the head injury
timeFrame: 18 months
measure: Prevalence of ongoing symptoms relating to the head injury
timeFrame: 18 months
measure: Identification of early predictors of adverse clinical outcome
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Sheffield
name: Suzanne Mason, MD
role: PRINCIPAL_INVESTIGATOR
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