TICH-2 (substudy)
Trial question
What is the role of tranexamic acid on remote cerebral ischemic lesions in acute spontaneous intracerebral hemorrhage?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 219
219 patients (93 female, 126 male).
Inclusion criteria: adult patients with acute spontaneous intracerebral hemorrhage who underwent MRI.
Key exclusion criteria: ICH secondary to anticoagulation; thrombolysis, contraindication to study drug; trauma or a known underlying structural abnormality.
Interventions
N=96 tranexamic acid (1 g in 100 mL intravenous bolus, followed by 1 g in 250 mL infusion within 8 hours of hemorrhage onset).
N=123 placebo (0.9% saline within 8 hours of hemorrhage onset).
Primary outcome
Diffusion-weighted imaging hypertense lesions
20.8%
22.8%
22.8 %
17.1 %
11.4 %
5.7 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
No significant difference in DWI hypertense lesions (20.8% vs. 22.8%; OR 0.71, 95% CI 0.33 to 1.53).
Secondary outcomes
No significant difference in mean number of DWI hypertense lesions (1.75 vs. 1.81; MD -0.08, 95% CI -0.36 to 0.2).
Conclusion
In adult patients with acute spontaneous intracerebral hemorrhage who underwent MRI, tranexamic acid was not superior to placebo with respect to a DWI hypertense lesions.
Reference
Stefan Pszczolkowski, Nikola Sprigg, Lisa J Woodhouse et al. Effect of Tranexamic Acid Administration on Remote Cerebral Ischemic Lesions in Acute Spontaneous Intracerebral Hemorrhage: A Substudy of a Randomized Clinical Trial. JAMA Neurol. 2022 May 1;79(5):468-477.
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