Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3)
- Conditions
- StrokeTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2022-500587-35-01
- Lead Sponsor
- niversity Of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5610
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice.<br>Primary objective: To assess the effect of TXA on early death (=7days);Secondary Objective: To assess the effect of TXA on dependency 6 months after ICH;Primary end point(s): Primary outcome: Early death up to and including day 7 after ICH onset. Justification of primary outcome: Functional outcome using the mRS at 90 days is the recommended outcome measure after stroke. However, our hypothesis is that TXA improves outcome by stopping HE. HE is the most common cause of early death after ICH, TXA is a haemostatic therapy, therefore we believe early mortality =7 days is the most appropriate outcome for TICH-3.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):To assess the effect of TXA on dependency 6 months after ICH