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Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3)
EU CTIS ID: 2022-500587-35-01
What this study is testing
To assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice. Primary objective: To assess the effect of TXA on early death (≤7days)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria: 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Malaysia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Malaysia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.