Eligibility

Local study conflicts

• No co-enrolment conflicts

Inclusion Criteria:

• Informed consent obtained from participant / participants’ legal representative and ability to comply with the requirements of the trial
• 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
• At high risk for thromboembolic complications (CHA2DS2-VASc ≥2 in men and ≥3 in women)

Exclusion Criteria:

• Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma only
• Patients with a mechanical heart valve
• Patients with a plan to start/restart anti-platelet therapy within 12 weeks of tICrH
• Abbreviated Injury Scale other than head with a score >3
• Pregnant or nursing female
• For participants of reproductive potential (males and females), not willing to use of a reliable means of contraception*
• Participants with a hypersensitivity or contraindication to Direct Oral Anticoagulant (DOAC) as detailed in each IMP SmPC
• Participant with bleeding where it would be unsafe to restart DOAC at 1 week
• Participant with clinical reason to restart DOAC before 4 weeks or complete within 12 weeks
• Concomitant p-gp and CYP3A4 inducers/inhibitors
• Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g. severe renal impairment)
• * Contraception must be followed by study participants (males and females) for the duration of their participation in the clinical trial. Contraception requirements are only needed for female participants where they are women of child bearing potential (WOCBP). The definition of WOCBP is: “fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy
  (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required”.
  The following are acceptable methods of contraception based on the clinical trials facilitation group (CTFG) guidance:
  (- For information only. You don't need to discuss contraception with the patient before contacting the research team to notify them there is a potentially eligible patient in the department)
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
  • Oral
  • Intravaginal
  • Transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation:
  • Oral
  • Injectable
  • Implantable
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner
  • Sexual abstinence - The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are NOT acceptable methods of contraception.
• Monthly pregnancy test is also required in WOCBP for the duration of the participation in the trial (ie. until the final visit at week 26). It would be acceptable for a pregnancy test to be performed on-site or at the participants home.

If the patient is eligible:

Step by Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Friday 07:30 – 18:30


• Contact the EMROx research team on:
  Mobile 0776818242
  Tel 01865 222003
  Bleep 6680

Out of hours and at weekends:

• Patients can only be recruited during the research team's working hours.