Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3) - 21022

niversity Of Nottingham0 个研究点目标入组 5,610 人开始时间: 2023年1月18日最近更新: 2024年8月21日

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•i. Adults (= 18 years) ii. Presenting within 4.5 h of onset of acute spontaneous ICH iii. ICH confirmed on brain imaging iv. When onset of symptoms is unknown patient must be within 4.5 hours of symptom discovery and have no other exclusion criteria. v. Patients taking direct oral anticoagulants can be included vi. Informed consent according to Article 35 of (EU) No 536/2014 vii. Please see separate document for EU country specific Descriptors – see Protocol Appendix 2 and Part II document

•Exclusion Criteria: viii. Patient with a known recommended indication for TXA treatment (e.g. traumatic brain injury). ix. Patients with contraindication to TXA in view of treating physician should be excluded. I.e where the contraindication outweighs the risk of giving TXA to a patient as an emergency ICH treatment: a. Active seizures b. Current diagnosis of acute venous or arterial thrombosis c. Hypersensitivity to TXA or normal saline d. Patients with known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumor. An underlying structural abnormality does not need to be excluded before enrolment, but where known, patients should not be recruited. x. Patient known to be taking therapeutic anticoagulation with warfarin or low molecular weight heparin at time of enrolment. Patients taking direct oral anticoagulants are not excluded xi. Massive ICH for which haemostatic treatment seems futile (This would ordinarily be when haematoma volume is estimated as larger than 60ml) xii. Severe coma (Glasgow Coma Scale <5) xiii. Decision already taken for palliative (end of life) care with withdrawal of active treatment

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niversity Of Nottingham