Intravenous Tranexamic Acid for Subdural and Epidural Intracranial Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

医学 氨甲环酸 麻醉 安慰剂 双盲 随机对照试验 硬膜下出血 外科 失血 血肿 替代医学 病理
作者
Pouya Ebrahimi,Javad Mozafari,Reza Bahrami,Mohammad Ghasem Hanafi,Maryam Mousavinejad
出处
期刊:Reviews on Recent Clinical Trials [Bentham Science Publishers]
卷期号:14 (4): 286-291 被引量:32
标识
DOI:10.2174/1574887114666190620112829
摘要

Background: Recovery of patients with traumatic brain injury largely depends on the reduction in secondary brain damage. The present study aims at investigating the effect of Tranexamic Acid (TXA) administration within the first hours of brain trauma in the emergency department (ED). Methods: This randomized, double-blind, placebo-controlled clinical trial was carried out in patients with subdural and epidural hemorrhage. Patients with any type of bleeding were assigned into two groups of TXA and 0.9% normal saline as placebo. The rate of intracranial hemorrhage after surgery was assessed by CT-scan and amount of hemoglobin (Hb) was measured immediately before surgery and after 6 hours of surgery. Results: A total of 80 participants were randomly assigned into four groups of 20 people. There was a significant difference in the mean of intraoperative bleeding during surgery in patients receiving TXA and placebo in both SDH (Subdural hematoma) and EDH (Epidural Hemorrhage) groups (P= 0.012). The Hb drop amount had no significant difference with placebo (P< 0.0001). No complications were observed in any of the intervention and control groups during the study as well. Conclusion: The use of TXA may reduce bleeding, however, based on the results of this study, such effect was not statistically significant in controlling the epidural and subdural hemorrhage, but clinical trials with a higher sample size are suggested for further investigation in this regard.
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