RESTART tICrH
Research type
Research Study
Full title
Restart tICrH: A Randomised Trial of Timing to Restart Direct Oral Anticoagulants after Traumatic Intracranial Haemorrhage
IRAS ID
1008878
Contact name
Catherine McMahon
Contact email
Sponsor organisation
The Walton Centre NHS Foundation Trust
ISRCTN Number
ISRCTN63161604
Clinicaltrials.gov Identifier
Research summary
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.
The RESTART tICrH 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 DOAC for previously diagnosed medical condition (e.g., atrial fibrillation). 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. This will be randomly assigned by a computer. They will be then followed closely for 26 weeks and any major bleeding events or a blood clots (thrombotic events) such as a stroke or heart attack will be recorded.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0298
Date of REC Opinion
14 Oct 2024
REC opinion
Further Information Favourable Opinion