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RECRUITINGPhase 3INTERVENTIONAL

Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

A Randomised Trial of Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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). This trial will recruit 1084 people who are admitted to hospital with a bleed on the brain caused by a head injury who were taking oral anticoagulation before their head injury and have been prescribed a Direct Oral Anti-Coagulant (DOAC) for previously diagnosed medical condition. Patients on other Oral Anti-Coagulants, such as Warfarin may also be able to take part. The main purpose of the trial is to determine when is most beneficial time for people to start or restart a DOAC after their head injury. People will be asked to start the medication either 1 week or 4 weeks after their head injury. They will be then followed closely for 12 weeks and any major bleeding events or a blood clots (thrombotic events) such as a stroke or heart attack will be recorded. The study will also look at the person's overall quality of life, how they recover physically, the number of people who die, the costs of the treatment, and the attitudes of people and their caregivers to starting or restarting a DOAC.

Who May Be Eligible (Plain English)

Who May Qualify: 1. willing to sign a consent form 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) Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

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

Direct-acting oral anticoagulants to be prescribed as per local standard practice at either 1 or 4 weeks.

Locations (2)

University Hospitals Plymouth NHS Trust
Plymouth, Devon, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, Mersyside, United Kingdom