Actively Recruiting

Phase 3
All Genders
NCT06322953

Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

Led by Walton Centre NHS Foundation Trust · Updated on 2025-04-04

1084

Participants Needed

2

Research Sites

177 weeks

Total Duration

On this page

Sponsors

W

Walton Centre NHS Foundation Trust

Lead Sponsor

U

University of Liverpool

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent obtained from participant or legal representative
  • Adults aged 18 years or older with traumatic intracranial haemorrhage within the past 1 week
  • Taking oral anticoagulants (DOAC or Vitamin K antagonist) prior to admission for atrial fibrillation or venous thromboembolism
  • High risk for thromboembolic complications (CHA2DS2VASc score 2 in men and 3 in women)
Not Eligible

You will not qualify if you...

  • Traumatic intracranial haemorrhage is a chronic subdural haematoma
  • Mechanical heart valve present
  • Planned start or restart of anti-platelet therapy within 12 weeks of brain bleed
  • Abbreviated Injury Scale score greater than 3 outside of head injury
  • Pregnancy
  • Hypersensitivity or contraindication to Direct Oral Anticoagulants
  • Unsafe to restart DOAC at 1 week due to bleeding risk
  • Clinical need to restart DOAC before 4 weeks or complete within 12 weeks
  • Use of medications that strongly interact with DOAC metabolism
  • Medical indication to remain on Vitamin K antagonist rather than switch to DOAC (e.g., severe kidney problems)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospitals Plymouth NHS Trust

Plymouth, Devon, United Kingdom, PL6 8DH

Actively Recruiting

2

The Walton Centre NHS Foundation Trust

Liverpool, Mersyside, United Kingdom, L9 7LJ

Actively Recruiting

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Research Team

L

Laura Wright

CONTACT

B

Ben Hardwick

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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