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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Catherine McMahon
+44 (0)161 789 7373
catherine.mcmahon@nca.nhs.uk


Dr Laura Wright
+44 (0)151 795 0600
restart.trial@liverpool.ac.uk


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Be Part of Research - Trial Details - A study to test different times for starting direct oral anticoagulants again after someone has had bleeding in their brain due to an injury
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A study to test different times for starting direct oral anticoagulants again after someone has had bleeding in their brain due to an injury

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Traumatic intracranial haemorrhage

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 ongoing healthcare needs.
The main purpose of the trial is to determine when is the most beneficial time for people to start or restart a direct oral anticoagulant (DOAC) after their head injury.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Sep 2024 30 Jun 2027

People will be asked to start the medication either 1 week or 4 weeks after their head injury. This will be randomly assigned by a computer. They will be then followed closely for 26 weeks and any major bleeding events or blood clots (thrombotic events) such as a stroke or heart attack will be recorded.


Patients aged 18 years and over 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 DOAC for a previously diagnosed medical condition (e.g., atrial fibrillation). Patients on other oral anti-coagulants such as warfarin may also be able to take part.

You can take part if:



You may not be able to take part if:


1. Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma only2. Patients with a mechanical heart valve3. Patients with a plan to start/restart anti-platelet therapy within 12 weeks of tICrH4. Abbreviated Injury Scale other than head with a score >35. Pregnant or nursing female6. For participants of reproductive potential (males and females), not willing to use a reliable means of contraception*7. Participants with a hypersensitivity or contraindication to Direct Oral Anticoagulant (DOAC)8. Participant with bleeding where it would be unsafe to restart DOAC at 1 week9. Participant with clinical reason to restart DOAC before 4 weeks or complete within 12 weeks10. Concomitant p-gp and CYP3A4 inducers/inhibitors11. Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g. severe renal impairment)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Both timepoints for restarting oral anticoagulants have been shown to improve symptoms but it is not known which timescale is best. In normal clinical care patients will restart oral anticoagulants 1-4 weeks after head injury so this study will not put participants at any additional risk. Participants will receive only CT or MRI scans as they would normally for standard of care so there is not expected to be any additional risk for participants.

Dr Catherine McMahon
+44 (0)161 789 7373
catherine.mcmahon@nca.nhs.uk


Dr Laura Wright
+44 (0)151 795 0600
restart.trial@liverpool.ac.uk



The study is sponsored by The Walton Centre NHS Foundation Trust and funded by Health Technology Assessment Programme.



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Read full details for Trial ID: ISRCTN63161604

Or CPMS 65417

Last updated 06 November 2024

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