TICH-2
Trial question
What is the effect of tranexamic acid in patients with stroke due to intracerebral hemorrhage?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 2325
2325 patients (1024 female, 1301 male).
Inclusion criteria: adult patients with intracerebral hemorrhage from acute stroke.
Key exclusion criteria: intracerebral hemorrhage secondary to anticoagulation, thrombolysis, trauma, or a known underlying structural abnormality; contraindication to tranexamic acid; prestroke dependence; life expectancy < 3 months; and GCS score < 5.
Interventions
N=1161 tranexamic acid (1 g intravenous bolus followed by another 1 g infused over 8 hours, within 8 hours of symptom onset).
N=1164 placebo (normal saline 0.9% administered with an identical regimen).
Primary outcome
Death at 90 days
22%
21%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
No significant difference in death at 90 days (22% vs. 21%; aHR 0.92, 95% CI 0.77 to 1.1).
Secondary outcomes
Significant decrease in change in volume of hematoma from baseline to 24 hours (3.72 mL vs. 4.9 mL; AD -1.37 mL, 95% CI -2.71 to -0.04).
Significant increase in length of stay in hospital (63.12 days vs. 63.73 days; AD 1.09 days, 95% CI 0.97 to 1.24).
Safety outcomes
No significant differences in venous thromboembolic events, arterial occlusions, seizure, nervous system disorders, infections.
Significant differences in serious adverse events by day 2 (33% vs. 36%), day 7 (39% vs. 43%), 90 days (45% vs. 48%).
Conclusion
In adult patients with intracerebral hemorrhage from acute stroke, tranexamic acid was not superior to placebo with respect to death at 90 days.
Reference
Nikola Sprigg, Katie Flaherty, Jason P Appleton et al. Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial. Lancet. 2018 May 26;391(10135):2107-2115.
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