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Timing blood thinners after head injury: a delicate balance between bleeding and stroke risk

NCT ID NCT06322953

Disease control Sponsor: Walton Centre NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates the safest time to restart direct oral anticoagulants (DOACs) after a traumatic brain bleed. Many older adults who fall and hit their head are on blood thinners for conditions like atrial fibrillation, and stopping them raises the risk of stroke or clots. The study will compare restarting DOACs at 1 week versus 4 weeks after injury, tracking major bleeding or clotting events over 12 weeks. About 1,084 participants will be followed to see which timing offers the best balance of safety and protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Direct oral anticoagulants (DOACs) such as apixaban, dabigatran, edoxaban, or rivaroxaban
What this could lead to
If it works, this could establish the safest time to restart blood thinners after a head injury, reducing the risk of both further bleeding and strokes.
What could go wrong
This is a single trial, and results may not apply to all patients. There is still a risk of bleeding or clotting regardless of timing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,084 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Informed consent obtained from participant / participants' 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) 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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Conditions

The condition(s) this trial relates to.

Intracranial Hemorrhage, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic intracranial haemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Walton Centre NHS Foundation Trust

    RECRUITING

    Liverpool, Mersyside, L9 7LJ, United Kingdom

  • University Hospitals Plymouth NHS Trust

    RECRUITING

    Plymouth, Devon, PL6 8DH, United Kingdom