Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

Launched by WALTON CENTRE NHS FOUNDATION TRUST · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the best time to restart a specific type of blood-thinning medication called Direct Oral Anticoagulants (DOACs) for patients who have had a bleed in the brain due to a head injury. Many older adults, who often take these medications for conditions like irregular heartbeat or blood clots, are at risk of serious complications if their blood thinners are stopped too long. The trial aims to find out if starting the medication one week or four weeks after the head injury is safer and more beneficial for patients.

To participate, individuals need to be at least 18 years old and have experienced a traumatic brain bleed within the last week while already being on anticoagulant therapy. They will be monitored for 12 weeks after starting the medication to see how well they recover, any major bleeding or blood clot incidents, and their overall quality of life. This study is important because it not only aims to improve safety for patients but also addresses patient preferences regarding their treatment after a head injury. If you or a loved one is interested in participating, please consult with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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 (VKA) (e.g. Warfarin), prescribed for atrial fibrillation (AF) or venous thromboembolism (VTE) prior to admission for tICrH
• • 4. At high risk for thromboembolic complications (CHA2DS2VASc ≥2 in men and ≥3 in women)
• Exclusion Criteria:
• • 1. Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma
• • 2. Patients with mechanical heart valve
• • 3. Patients with plan to start/restart anti-platelet therapy within 12 weeks of tICrH
• • 4. Abbreviated Injury Scale other than head with a score \>3
• • 5. Pregnancy
• • 6. Participants with a hypersensitivity or contraindication to Direct Oral Anticoagulant (DOAC)
• • 7. Participant with bleeding where it would be unsafe to restart DOAC at 1 week
• • 8. Participant with clinical reason to restart DOAC before 4 weeks or complete within 12 weeks
• • 9. Concomitant p-gp and CYP3A4 inducers/inhibitors
• • 10. Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g. severe renal impairment)