title: Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design.
abstract: 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 8 h 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 >6 ml from baseline to 24 ± 2 h. 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.
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Liu
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Yilong
authors.initials: Y
authors.lastname: Wang
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Meng
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Na
authors.initials: N
authors.lastname: Li
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Tan
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Ximing
authors.initials: X
authors.lastname: Nie
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Dacheng
authors.initials: D
authors.lastname: Liu
authors.affiliation: 1 Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Xingquan
authors.initials: X
authors.lastname: Zhao
mesh_terms: D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D001921:Brain / Q000000981:diagnostic imaging / Q000187:drug effects; D002543:Cerebral Hemorrhage / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D006801:Humans; D012107:Research Design; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D014148:Tranexamic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid
keywords: Intracerebral hemorrhage; antifibrinolytic therapy; hemorrhage growth; spot sign; tranexamic acid