The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Completed

• Conditions: Head Injuries, Closed; Craniocerebral Trauma

• Registration Number: NCT02461498
• Lead Sponsor: University of Sheffield

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).

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-29
• Last Update Submitted: 2015-05-29
• Study First Posted: 2015-06-03
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3556

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of head injury complication in study cohort	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 Outcome Measures

Name	Time	Method
Prevalence of ongoing symptoms relating to the head injury	18 months	Impaired cognitive function (assessed by the Glasgow Outcome Scale)
Identification of early predictors of adverse clinical outcome	18 months	Including clinical features and initial investigations which may be useful as a diagnostic tool.