Restart tICrH: a randomised trial of timing to restart direct oral anticoagulants after traumatic intracranial haemorrhage
Traumatic intracranial haemorrhage
Participants will be randomised to one of the two arms using an online randomisation system: Start/Restart DOAC at 1 week – Participants will be restarted/started on DOAC 1 week post-traumatic intracranial haemorrhage Start/Restart DOAC at 4 weeks – Participants will be restarted/started on DOAC 4 weeks post-traumatic intracranial haemorrhage DOACs prescribed with dose, frequency and duration as per local standard practice. DOACs commonly used are apixaban, dabigatran etexilate mesilate, edoxaban and rivaroxaban. These are to be restarted at either 1 or 4 weeks post tICrH.
Current participant inclusion criteria as of 11/06/2026; 1. Informed consent obtained from the participant/participant’s 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)/ atrial flutter, or venous thromboembolism (VTE) prior to admission for tICrH) Previous participant inclusion criteria as of 06/06/2025: 1. Informed consent obtained from the participant/participant’s legal representative and the 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) Previous participant inclusion criteria: 1. Informed consent obtained from participant/participants’ legal representative/participants’ Consultee 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 3. 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 4. At high risk for thromboembolic complications (CHA2DS2-VASc ≥2 in men and ≥3 in women)
Current participant exclusion criteria as of 11/06/2026: 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. Severe polytrauma or life-threatening injury where there is a contraindication to restarting anticoagulation 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. Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g., severe renal impairment) Previous participant exclusion criteria as of 06/06/2025: 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 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) Previous participant exclusion criteria: 1. Patients whose traumatic intracranial haemorrhage is a