protocolSection identificationModule nctId: NCT06322953, orgStudyIdInfo id: RG442-21, briefTitle: Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage, acronym: RESTARTtlCrH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Walton Centre NHS Foundation Trust, class: OTHER, collaborators name: University of Liverpool, collaborators name: National Institute for Health Research, United Kingdom, descriptionModule briefSummary: 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., conditionsModule conditions: Traumatic Intracranial Haemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1084, type: ESTIMATED, armsInterventionsModule interventions name: Direct-Acting Oral Anticoagulants (used as per local standard practice), outcomesModule primaryOutcomes measure: Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH., secondaryOutcomes measure: Time to first haemorrhagic or thrombotic event., secondaryOutcomes measure: Time to first haemorrhagic event, secondaryOutcomes measure: Time to first thrombotic event, secondaryOutcomes measure: Time to death, secondaryOutcomes measure: Functional outcome measured using modified Rankin Scale (mRS), secondaryOutcomes measure: Functional outcome measured using Barthel Index, secondaryOutcomes measure: Functional outcome measured using extended Glasgow Outcome Scale (GOS-E), secondaryOutcomes measure: Overall Quality of Life measured by EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire, secondaryOutcomes measure: Patient/caregiver attitudes to (re)starting OAC, secondaryOutcomes measure: Healthcare resource use, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False