国家神经系统疾病临床医学研究中心数据管理与共享系统

Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

《国家中心数据管理与共享系统操作说明书 —— 研究者部分》

Tranexamic acid for acute intracerebral hemorrhage growth based on imaging assessment (TRAIGE): a multicenter; randomized; placebo-controlled trial

第一作者：刘婧伊

通讯作者：刘丽萍,王拥军

cerebral hemorrhage tranexamic acid hematoma spot sign blend sign black hole sign

基本信息

2021-04-01

已发表文章

发表杂志：Stroke and Vascular Neurology

发表类型: Original Research

影响因子(IF): 4.081

PMID: 33795488 Pubmed原文链接 全文下载

主要研究背景及目的

Studies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial hemorrhage. We aimed to assess whether tranexamic acid reduces hematoma expansion and improves outcome in intracerebral hemorrhage patients susceptible to hemorrhage expansion.

方法

We did a prospective, double-blind, randomized, placebo-controlled trial at 10 stroke centers in China. Acute supratentorial intracerebral hemorrhage patients were eligible if they had indication of hemorrhage expansion on admission imaging (e.g., 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 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo (saline). The primary outcome was intracerebral hematoma growth (>33% relative or >6 mL absolute) at 24 h. Clinical outcomes were assessed at 90 days. This trail is registered at ClinicalTrials.gov (NCT02625948).

结论

Among patients susceptible to hemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral hemorrhage growth. We found it was safe and caused less 90-day death. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral hemorrhage patients.

主要结果

Of the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. Baseline mean intracranial hemorrhage volume was 23.7±18.7 ml. 89 patients received tranexamic acid and 82 received placebo. The treatment groups were well balanced at baseline. 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 hemorrhage growth (odds ratio [OR] 0.96 [95% CI 0.52-1.77], p=0.89). Less proportion of death were observed in tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial hemorrhage growth, death, and dependency. Major thromboembolic events occurred in 2 patients, 1 in each group (P=0.96).