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Published on: January 18, 2018
Timing to restart direct oral anticoagulants after traumatic intracranial haemorrhage (RESTART tICrH): study protocol
Ellie Edlmann1,2, Siddarth Kannan3, Laura Wright4
1Department of Neurosurgery, University of Plymouth, Plymouth, UK.
Background:
Head injury in older adults is increasingly common, often caused by low-impact falls. A significant proportion of these patients are taking oral anticoagulants (OACs) to prevent stroke or thromboembolism. When traumatic bleeding within the head occurs, OACs are usually stopped to reduce the risk of worsening haemorrhage; however, prolonged interruption increases the risk of stroke, systemic thromboembolism and death. There is currently no consensus on when it is safest to restart OACs. Direct oral anticoagulants (DOACs) are now widely prescribed and may offer advantages over warfarin. This trial aims to determine the safest and most effective timing to start/restart a DOAC after a traumatic intracranial haemorrhage (tICH).
Methods:
This is a phase III, multi-centre, randomised controlled trial. Adults with tICH who were taking an OAC before injury will be recruited across approximately 20 trauma networks in the UK. Eligible participants will be randomised to restart DOAC therapy either 1 week or 4 weeks after tICH. The primary outcome is the proportion of patients with a haemorrhagic or thrombotic event within 12 weeks of tICH. Secondary outcomes include time-to-first haemorrhagic or thrombotic event, survival, functional status, quality of life and health resource use. Follow-up will occur at 6, 12 and 26 weeks, with data analysed on an intention-to-treat basis. Health economic and qualitative sub-studies will run alongside the main trial.
Discussion:
This study addresses a major area of clinical uncertainty. By directly comparing 1-week versus 4-week re-initiation of OAC, this trial will provide robust evidence to guide clinical practice in a tICH population at high risk of both bleeding and thrombotic complications. Findings will inform patient counselling, acute care protocols and guideline development.
Ethics And Dissemination Section:
Ethical approval has been obtained from the Berkshire Research Ethics Committee (24/SC/0298). Written informed consent will be obtained from all participants or their legal representatives before enrolment. Findings will be disseminated through peer-reviewed publications, scientific conferences, trial registry reporting and patient-facing summaries, with the aim of informing future guidance on anticoagulation management following tICrH.
Trial Registration:
NCT06322953.
