Stroke - primary intracerebral haemorrhage Circulatory System Stroke
Conditions
Interventions
Intravenous tranexamic acid (Cyklokapron®) or 0.9% normal saline administered as 1 g loading dose infusion over 10 minutes followed by 1 g infusion over 8 hours.
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged over 18 years, either sex) with primary intracerebral haemorrhage confirmed on computed tomography (CT) brain scan 2. Event less than 24 hours of onset (sleep stroke - onset as bed time)
Exclusion criteria
Exclusion criteria: 1. Secondary haemorrhagic stroke (anticoagulation, known vascular malformations) 2. Previous venous thrombo-embolic disease 3. Recent (within 12 months) ischaemic events (ischaemic stroke, myocardial infarction, peripheral artery disease) 4. Renal impairment (estimated glomerular filtration rate [eGRF] less than 50 mmol) 5. Pregnancy or breast feeding (pregnancy will be excluded in female patients of child bearing age with a urine pregnancy test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability: number of patients screened that are eligible for enrolment that give informed consent 2. Tolerability: adverse events after tranexamic acid administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Surrogate markers of efficacy: 1. Radiological: haematoma volume change on brain imaging Day 1 to Day 2 2. Haematological: full blood count (FBC) and clotting function at Day 2 3. Day 7 (or discharge from hospital) and Day 90 (end of follow-up): 3.1. Dependency (modified Rankin Scale shift) 3.2. Disability (change in BI) 3.3. Quality of life (EuroQoL) 3.4. Care giver burden (GHQ-28) 3.5. Mood (Zung depression score) 3.6. Cognition (MMSE) | — |
Countries
United Kingdom
Outcome results
None listed