EUCTR2012-004108-37-ESActive, not recruitingPhase 1
Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage TICH-2 - Tranexamic acid for IntraCerebral Haemorrhage TICH-2
niversity of Nottingham0 sites2,325 target enrollmentStarted: December 16, 2014Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,325
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Adult (?18 years) patients with acute PICH within 8 hours of stroke onset. (Where stroke onset time is unknown, the time of when last known well will be used.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 667
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1333
Exclusion Criteria
- •1)Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arterial venous malformation, aneurysm, tumour, venous thrombosis as cause for the intracerebral haemorrhage.. Note it is not necessary to exclude an underlying abnormality prior to enrolment, but where a secondary cause of haemorrhage is known, these patients should not be recruited.
- •2)Patients for whom tranexamic acid is thought to be contraindicated.
- •3)Patients with pre-morbid dependency (mRS>4).
- •4)Participation in another drug trial concurrently.
- •5)Pre-stroke life expectancy <3 months (eg. advanced metastatic cancer).
- •6)Coma ? Glasgow coma scale <5
Investigators
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