Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design
Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design
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DOI：
10.1177/1747493017694394
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发表时间：
2017-04-01
影响因子：
6.7
通讯作者：
Zhao, Xingquan
中科院分区：
文献类型：
--
作者：
Liu, Liping;Wang, Yilong;Zhao, Xingquan
原理：急性脑出血造成高经济和健康负担。计算机断层血管造影斑点征象是血肿扩张的预测指标，与临床预后不良相关，是止血治疗患者的重要分层变量。我们的目的是比较氨甲环酸治疗与安慰剂治疗对有阳性斑点征像的高危急性脑出血患者出血生长的预防效果。通过斑点体征预测急性脑出血生长的氨甲环酸（TRAIGE）是一项前瞻性、多中心、安慰剂对照、双盲、研究者主导的随机临床试验，将包括约240名参与者。脑出血患者在8小时内出现症状，并有斑点体征作为持续出血的生物标志物，无抗纤溶治疗禁忌症，将入组接受氨甲环酸或安慰剂治疗。主要结局指标是是否存在出血增长，定义为脑出血容量从基线到242h增加33%或6ml。次要结局包括安全性和临床结局。结论TRAIGE试验评价了氨甲环酸止血治疗对高危急性脑出血患者出血生长的预防作用。
Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy.Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign.Design The tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign (TRAIGE) is a prospective, multicenter, placebo-controlled, double-blind, investigator-led, randomized clinical trial that will include an estimated 240 participants. Patients with intracerebral hemorrhage demonstrating symptom onset within 8h and with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy, will be enrolled to receive either tranexamic acid or placebo. The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6ml from baseline to 242h. The secondary outcomes include safety and clinical outcomes.Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.