Stroke
Conditions
Brief summary
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.
Detailed description
To assess the effect of TXA on dependency 6 months after ICH
Interventions
DRUGCyklokapron 100mg/mL solution for injection/infusion
Sponsors
University Of Nottingham
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the effect of TXA on dependency 6 months after ICH | — |
Countries
Denmark, Finland, France, Ireland, Italy, Norway, Spain, Sweden
Outcome results
None listed