RT Journal Article
SR Electronic
T1 Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP svn-2021-000942
DO 10.1136/svn-2021-000942
A1 Jingyi Liu
A1 Ximing Nie
A1 Hongqiu Gu
A1 Qi Zhou
A1 Haixin Sun
A1 Ying Tan
A1 Dacheng Liu
A1 Lina Zheng
A1 Jiahui Zhao
A1 Yan Wang
A1 Yibin Cao
A1 Haomeng Zhu
A1 Yunpeng Zhang
A1 Lijin Yi
A1 Yuehua Pu
A1 Miao Wen
A1 Zhonghua Yang
A1 Shengjun Sun
A1 Wenzhi Wang
A1 Xingquan Zhao
A1 Liping Liu
A1 Yongjun Wang
YR 2021
UL http://svn.bmj.com/content/early/2021/04/01/svn-2021-000942.abstract
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.