PT  - JOURNAL ARTICLE
AU  - Liu, Jingyi
AU  - Nie, Ximing
AU  - Gu, Hongqiu
AU  - Zhou, Qi
AU  - Sun, Haixin
AU  - Tan, Ying
AU  - Liu, Dacheng
AU  - Zheng, Lina
AU  - Zhao, Jiahui
AU  - Wang, Yan
AU  - Cao, Yibin
AU  - Zhu, Haomeng
AU  - Zhang, Yunpeng
AU  - Yi, Lijin
AU  - Pu, Yuehua
AU  - Wen, Miao
AU  - Yang, Zhonghua
AU  - Sun, Shengjun
AU  - Wang, Wenzhi
AU  - Zhao, Xingquan
AU  - Liu, Liping
AU  - Wang, Yongjun
TI  - Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial
AID  - 10.1136/svn-2021-000942
DP  - 2021 Jun 01
TA  - Stroke and Vascular Neurology
PG  - 160--169
VI  - 6
IP  - 2
4099  - http://svn.bmj.com/content/6/2/160.short
4100  - http://svn.bmj.com/content/6/2/160.full
SO  - Stroke Vasc Neurol2021 Jun 01; 6
AB  - 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 intracranial haemorrhage growth, death and dependency.Conclusions Among patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.Data are available on reasonable request. All data are available to researchers on request for purposes of reproducing the results or replicating the procedure by directly contacting the corresponding author.