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โ† Trials
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Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

RecruitingPhase 3Ages 18 Years - anyAllWalton Centre NHS Foundation Trust
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In plain words

What the trial is, and whether it could suit you

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. T

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Informed consent obtained from participant / participants' legal representative and ability to comply with the requirements of the trial 2. Adult โ‰ฅ18 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) Exclusion Criteria: 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)
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What it tests

  • Direct-Acting Oral Anticoagulants (used as per local standard practice)
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Where

2 sites
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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