Primary Intracerebral Haemorrhage MedDRA version: 14.1 Level: LLT Classification code 10022753 Term: Intracerebral haemorrhage System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Cyklokapron
Product Name: Cyklokapron
Pharmaceutical Form: Injection
INN or Proposed INN: tranexamic acid
CAS Number: 1197-1
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH).;Timepoint(s) of evaluation of this end point: Death or dependency (ordinal shift on mRS) at day 90 will be compared between tranexamic acid and saline.;Main Objective: To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH).;Secondary Objective: To assess the effect of tranexamic acid on secondary outcomes: clinical outcomes, safety outcomes, costs and radiological efficacy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Neurological impairment (NIHSS) at day 7 or discharge if sooner. 2. Disability (Barthel index) at day 90, 3. Quality of Life (EuroQol) at day 90, 4. Cognition at day 90. 5. Costs: length of stay in hospital, re-admission, institutionalisation. 6. Radiological efficacy/safety (CT scan): change in haematoma volume from baseline to day 2, haematoma location and new infarction. ; Timepoint(s) of evaluation of this end point: See above for details: Day 2, Day 7 and 90 days | — |
Countries
Australia, Canada, Denmark, Egypt, Hong Kong, Hungary, India, Ireland, Italy, New Zealand, Poland, Romania, Spain, Sri Lanka, Sweden, United Kingdom
Outcome results
None listed