RecruitingPHASE3INTERVENTIONAL

Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

Many older people take blood-thinning medicines, called DOACs, often for irregular heartbeats or after a stroke. If they have a head injury that causes bleeding in the brain, these medicines are usually stopped. The big question is when it's safe to restart them. Restarting too soon could worsen the brain bleed, but waiting too long increases the risk of stroke or blood clots. This study will involve over 1,000 people who had a brain bleed due to a head injury and were taking a DOAC. Half will restart their DOAC after 1 week, and the other half after 4 weeks. Researchers will then carefully track them for 12 weeks to see who has new bleeds, strokes, or other problems, aiming to find the safest restart time.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Walton Centre NHS Foundation Trust

Enrolment target

1,084

Start

10 Mar 2025

Estimated completion

31 Jul 2028

Traumatic Intracranial Haemorrhage

What is this study about?

Imagine you're an older person enjoying life, but you take a medicine that thins your blood. This is often because you have an irregular heartbeat or have had a stroke before, and these medicines dramatically reduce your risk of serious blood clots. Now, what if you have a fall and hit your head, and doctors find a small bleed in your brain? Suddenly, this life-saving blood thinner becomes a concern because it could make the bleeding worse. For this reason, doctors almost always stop these medicines right away.

But stopping them presents a new problem: when is it safe to start them again? If you wait too long, you're at a higher risk of having a stroke or developing very dangerous blood clots. But if you restart too soon, you risk increasing the bleeding in your brain, which can also be very serious. Doctors currently don't have clear guidance on the best time to restart. This study aims to help answer that crucial question, comparing two common timings that doctors often suggest.

To do this, researchers will invite people who had a head injury that caused bleeding in their brain and were taking blood thinners (specifically DOACs) before their injury. These patients will be split into two groups. One group will be asked to restart their blood thinner about 1 week after their injury, and the other group will wait until about 4 weeks. Everyone will be carefully watched for 3 months to see if they have any new problems like more bleeding, a stroke, or a heart attack. The study will also look at how these different timings affect a person's recovery, their quality of life, and even the financial costs involved.

Key takeaways

Many older people on blood thinners face a dilemma after a head injury causing brain bleeding.
Stopping blood thinners reduces bleed risk but increases stroke risk.
This study compares restarting blood thinners at 1 week versus 4 weeks.
It aims to find the safest time to restart to balance bleeding and clotting risks.
The study will track health outcomes like bleeding, strokes, and quality of life for 12 weeks.

Who may be eligible?

This study is looking for adults aged 18 or over who have had a head injury in the past week that caused bleeding in their brain. Before their head injury, they must have been taking a blood-thinning medicine (like a DOAC or Warfarin) because of an irregular heartbeat or a history of blood clots, and be at a high risk for blood clots.

However, some people won't be able to join. This includes those whose brain bleed is a specific type called a 'chronic subdural haematoma' (a slow-forming clot), or those with certain heart problems like a mechanical heart valve. If you're pregnant, also have other severe injuries, or cannot take DOACs due to allergies or other medications, you won't be able to participate.

The study also won't include you if restarting a blood thinner at either 1 week or 4 weeks is considered unsafe for your specific situation. Also, if your doctor believes you absolutely need to restart your blood thinner much sooner than 4 weeks, or if you must stay on Warfarin for a specific medical reason, you likely won't be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 or older?
Did you have a head injury with brain bleeding in the last week?
Were you taking a blood thinner (like a DOAC or Warfarin) before your head injury?
Are you considered at high risk for blood clots?
Do you not have a mechanical heart valve or a specific type of brain bleed (chronic subdural haematoma)?
Are you not pregnant and don't have other severe injuries?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups by chance – like flipping a coin. One group will aim to restart their blood-thinning medicine (a DOAC) about 1 week after their head injury, and the other group will aim to restart it around 4 weeks after. You'll continue to take the DOAC you were prescribed before your injury, following standard local practice.

After restarting your medicine, you'll be carefully followed by the study team for a total of 12 weeks (about 3 months). During this time, they'll check for any major bleeding events, new blood clots (like a stroke or heart attack), and how you're recovering overall. This will involve regular check-ups and assessments. The study will also consider your feedback on your quality of life and how you and your caregivers feel about restarting these medicines.

Potential risks and benefits

Participating in this study might help doctors understand the best and safest time to restart crucial blood-thinning medications after a head injury. This could lead to better care for people like you in the future. However, there are potential risks, as restarting these medicines too early could worsen your brain bleed, and waiting too long could increase your risk of a stroke or blood clots. The researchers will closely monitor you for these events. Please remember, taking part is completely your choice, and you are free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Plymouth NHS Trust
Verified postcode
Plymouth, United Kingdom· Recruiting
The Walton Centre NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom· Recruiting

Common questions

What are DOACs?

DOACs are modern blood-thinning medicines, like Warfarin, that help prevent blood clots in people with certain heart problems or a history of clots.

Why is it important to restart these medicines?

For many people, these medicines are vital to prevent serious conditions like strokes or dangerous blood clots in other parts of the body.

Will I get to choose when I restart my medicine?

No, if you join, you'll be randomly assigned to either the 1-week or 4-week restart group, to help researchers compare the timings fairly.

What if I experience new problems during the study?

The study team will monitor you closely, and any new bleeds, strokes, or other issues will be recorded and managed by your doctors.

How long will I be involved in the study?

You'll be followed closely for about 12 weeks (3 months) after your head injury to see how you're doing.

How to find out more

Laura Wright

restart.trial@liverpool.ac.uk +44(0)151 795 8751 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.