Older people falling from a standing height is the most common cause of hospital admission for head injury. Up to 1 in 3 patients admitted are taking a tablet medication which thins the blood, known as an oral anticoagulant. This type of medication can increase the likelihood of bleeding in the brain. Many patients are taking oral anticoagulation due to having an irregular heartbeat (called atrial fibrillation) or because of having a previous stroke or blood clots. When a scan shows blood in the brain, oral anticoagulation is nearly always stopped. However, this leaves the question of when it is safe to restart them. The risk of making the bleeding in the brain worse must be balanced against the risk of having a stroke or blood clots.

There is no clear evidence on the safest time to restart oral anticoagulation, but most neurosurgeons advise restarting them 1-4 weeks after head injury. The number of people who have a bleed on their brain after a head injury is increasing and further brain bleeding or a stroke can have a serious effect on patients' lives and their on-going healthcare needs. Public and patient groups have highlighted that many patients want to stop taking oral anticoagulation after a bleed but they may be unaware of the vital importance of restarting this medication to prevent strokes and blood clots. The most popular oral anticoagulation prescribed has changed in recent years from warfarin to newer medications called Direct Oral Anti-Coagulants (DOACs).

The main purpose of the trial is to determine when the most beneficial time for people to start or restart a DOAC after their head injury is.

Participants will be assigned at random to start their DOAC medication:

• 1. One week after their head injury
• or
• 2. Four weeks after their head injury

Participants will be reminded when it is time to start or restart their DOAC (at 1 or 4 weeks) and will be followed up regularly for 6 months.

Adults with a traumatic intracranial haemorrhage (tICrH) who are taking oral anticoagulants (OAC)

If you think you may be eligible and would like to find out more about the study, you can enquire about the trial at your local hospital. If you want to find out more about the study but are not seeking to take part, contact restart.trial@liverpool.ac.uk

RESTART tICrH is being run in a number of hospitals around the UK.

• 1. Informed consent obtained from participant / participants’ legal representative and ability to comply with the requirements of the trial
• 2. Adult ≥18 years with traumatic intracranial haemorrhage (tICrH) in the past 1 week who were taking oral anticoagulants (OAC) prior to admission (Oral anticoagulants include any DOAC or Vitamin K antagonist (e.g. Warfarin), prescribed for atrial fibrillation (AF) or venous thromboembolism (VTE) prior to admission for tICrH)
• 3. At high risk for thromboembolic complications (CHA2DS2-VASc ≥2 in men and ≥3 in women) OR patients taking long term OAC for deep vein thrombosis (DVT) / pulmonary embolism (PE)

• 1. Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma only
• 2. Patients with a mechanical heart valve
• 3. Patients with a plan to start/restart anti-platelet therapy within 12 weeks of tICrH
• 4. Abbreviated Injury Scale other than head with a score >3
• 5. Pregnant or nursing female
• 6. For participants of reproductive potential (males and females), not willing to use of a reliable means of contraception
• 7. Participants with a hypersensitivity or contraindication to Direct Oral Anticoagulant (DOAC) as detailed in each IMP SmPC
• 8. Participant with bleeding where it would be unsafe to restart DOAC at 1 week
• 9. Participant with clinical reason to restart DOAC before 4 weeks or complete within 12 weeks
• 10. Concomitant p-gp and CYP3A4 inducers/inhibitors
• 11. Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g. severe renal impairment)

If you are interested in finding more out about the trial as a potential participant please read this brief participant letter.

If you would like detailed information about the trial then you can also review the full Patient Information Sheets.

• Adult Patient Information Sheet (PIS)
• Personal Legal Patient Information Sheet (PIS)
• Professional Legal Patient Information Sheet (PIS)

Coming soon – Patient Video