Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial.
Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial.
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DOI：
10.1136/svn-2021-000942
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发表时间：
2021-06
影响因子：
5.9
通讯作者：
Wang Y
中科院分区：
文献类型：
--
作者：
Liu J;Nie X;Gu H;Zhou Q;Sun H;Tan Y;Liu D;Zheng L;Zhao J;Wang Y;Cao Y;Zhu H;Zhang Y;Yi L;Pu Y;Wen M;Yang Z;Sun S;Wang W;Zhao X;Liu L;Wang Y
研究表明氨甲环酸可以降低颅内出血后死亡和早期神经功能恶化的风险。我们的目的是评估氨甲环酸是否减少血肿扩大，并改善对出血扩大敏感的脑出血患者的预后。我们在中国的10个卒中中心进行了一项前瞻性、双盲、随机、安慰剂对照试验。急性幕上脑出血患者如果入院时影像学检查显示出血扩大（例如，斑点征、黑洞征或混合征），并且在症状发作后8小时内可治疗，则符合资格。患者被随机分配（1：1）接受氨甲环酸或匹配的安慰剂。主要结局是24小时时脑内血肿生长（相对>33%或绝对>6 mL）。在90天时评估临床结局。在纳入的171例患者中，124例（72.5%）为男性，平均年龄为55.9±11.6岁。89名患者接受氨甲环酸，82名接受安慰剂。两组之间的主要结局无显著差异：氨甲环酸组36例（40.4%）患者和安慰剂组34例（41.5%）患者发生颅内出血增长（OR 0.96，95% CI 0.52 - 1.77，p=0.89）。氨甲环酸治疗组的死亡比例低于安慰剂组（8.1% vs 10.0%），但次要结局（包括绝对颅内出血增长、死亡和依赖性）无显著差异。在卒中发作8小时内接受治疗的易出血扩大患者中，氨甲环酸不能显著预防脑出血的扩大。需要更大规模的研究来评估氨甲环酸在脑出血患者中的安全性和有效性。
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. 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. 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. 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.
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影响因子：
8.2
作者：
An SJ;Kim TJ;Yoon BW
通讯作者：
Yoon BW
DOI：
10.1016/s1474-4422(18)30253-9
发表时间：
2018-10
期刊：
The Lancet. Neurology
影响因子：
--
作者：
Al-Shahi Salman R;Frantzias J;Lee RJ;Lyden PD;Battey TWK;Ayres AM;Goldstein JN;Mayer SA;Steiner T;Wang X;Arima H;Hasegawa H;Oishi M;Godoy DA;Masotti L;Dowlatshahi D;Rodriguez-Luna D;Molina CA;Jang DK;Davalos A;Castillo J;Yao X;Claassen J;Volbers B;Kazui S;Okada Y;Fujimoto S;Toyoda K;Li Q;Khoury J;Delgado P;Sabín JÁ;Hernández-Guillamon M;Prats-Sánchez L;Cai C;Kate MP;McCourt R;Venkatasubramanian C;Diringer MN;Ikeda Y;Worthmann H;Ziai WC;d'Esterre CD;Aviv RI;Raab P;Murai Y;Zazulia AR;Butcher KS;Seyedsaadat SM;Grotta JC;Martí-Fàbregas J;Montaner J;Broderick J;Yamamoto H;Staykov D;Connolly ES;Selim M;Leira R;Moon BH;Demchuk AM;Di Napoli M;Fujii Y;Anderson CS;Rosand J;VISTA-ICH Collaboration;ICH Growth Individual Patient Data Meta-analysis Collaborators
通讯作者：
ICH Growth Individual Patient Data Meta-analysis Collaborators
影响因子：
3.5
作者：
Koculym, A.;Huynh, T. J.;Aviv, R. I.
通讯作者：
Aviv, R. I.
影响因子：
6.7
作者：
Liu, Liping;Wang, Yilong;Zhao, Xingquan
通讯作者：
Zhao, Xingquan
影响因子：
48
作者：
Meretoja, Atte;Yassi, Nawaf;Davis, Stephen M.
通讯作者：
Davis, Stephen M.