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Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design

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机构: [1]Capital Med Univ, Beijing Tian Tan Hosp, Dept Neurol, 6 Tiantan Xili, Beijing, Peoples R China; [2]China Natl Clin Res Ctr Neurol Dis, Beijing, Peoples R China; [3]Beijing Inst Brain Disorders, Ctr Stroke, Beijing, Peoples R China
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关键词: Intracerebral hemorrhage spot sign hemorrhage growth antifibrinolytic therapy tranexamic acid

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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.

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出版当年[2016]版:
大类 | 2 区 医学
小类 | 3 区 外周血管病
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 临床神经病学 2 区 外周血管病
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出版当年[2015]版:
Q2 PERIPHERAL VASCULAR DISEASE
最新[2023]版:
Q1 CLINICAL NEUROLOGY Q1 PERIPHERAL VASCULAR DISEASE

影响因子: 最新[2023版] 最新五年平均 出版当年[2015版] 出版当年五年平均 出版前一年[2014版] 出版后一年[2016版]

第一作者:
第一作者机构: [1]Capital Med Univ, Beijing Tian Tan Hosp, Dept Neurol, 6 Tiantan Xili, Beijing, Peoples R China; [2]China Natl Clin Res Ctr Neurol Dis, Beijing, Peoples R China; [3]Beijing Inst Brain Disorders, Ctr Stroke, Beijing, Peoples R China
通讯作者:
通讯机构: [1]Capital Med Univ, Beijing Tian Tan Hosp, Dept Neurol, 6 Tiantan Xili, Beijing, Peoples R China; [2]China Natl Clin Res Ctr Neurol Dis, Beijing, Peoples R China; [3]Beijing Inst Brain Disorders, Ctr Stroke, Beijing, Peoples R China
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