Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

作者：Jing-Yi Liu, X. Nie, Hongqiu Gu, Qi Zhou, Hai-Xin Sun, Ying Tan, Da-Cheng Liu, Lina Zheng, Jia-Hui Zhao, Yan Wang, Yibin Cao, Hao-Meng Zhu, Yun-Peng Zhang, Li-Juan Yi, Y. Pu, Miao Wen, Zhong-Hua Yang, Sheng-Jun Sun, Wenzhi Wang, Xingquan Zhao, Liping Liu, Yongjun Wang · 发表于：Stroke and vascular neurology · 年份：2021 · DOI：10.1136/svn-2021-000942 · 被引用次数：59 · 研究领域：Medicine

Background Studies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion. Methods We did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days. Results Of the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracrani...