Head injury and DOACs
Research type
Research Study
Full title
Outcomes of patients presenting to the Emergency Department with a head injury and taking direct oral anticoagulants (DOACs).
IRAS ID
354101
Contact name
Gordon Fuller
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Duration of Study in the UK
0 years, 11 months, 26 days
Research summary
Head injury is a very common presentation to the Emergency Department (ED) and those patients taking direct oral anticoagulants (DOACs) present a management challenge to clinicians. There is a need for evidence to describe the risk of adverse outcomes to guide rational imaging decisions in these patients and understand the most appropriate management.
This study aims to determine the risk of adverse outcome in patients DOACs following head injury, identify low-risk subgroups that may not requite CT head scanning, and externally validate, the forthcoming CAN-SCAHn clinical decision rule for determining imaging in mild head injured patients taking anticoagulants.
This retrospective cohort study will be carried out in the Northern General (NGH) emergency department (ED), including adult patients presenting with a mild head injury (Glasgow Coma Scale score, GCS, 14-15) whilst taking a DOAC. Eligible cases will be identified by screening ED cases routinely coded as having a head injury and by reviewing electronic CT head requests from the ED. Patient demographic, injury, and outcome data will be collected locally by an ED researcher, who is also a member of the direct care team, into a secure spreadsheet hosted on the Sheffield Teaching Hospitals (STH) secure server.
Data will then be anonymised and securely downloaded to a STH laptop for data analysis. The risk of adverse outcome, comprising death (at 30 days) or neurosurgery resulting from initial injury, a clinically significant abnormality on CT scan attributable to the injury or re-attendance with a head injury-related complication within 30 days, will then be calculated. Risk of adverse outcome in two specific subgroups will also be investigated: GCS 15 and asymptomatic; and patients who have no NICE criteria for CT head imaging, beyond taking a DOAC. The discrimination and calibration of the forthcoming CAN-SCAHn clinical decision rule will also be calculated.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
25/NW/0067
Date of REC Opinion
7 Mar 2025
REC opinion
Favourable Opinion