Effect of Tranexamic Acid on Prevention of Hemorrhagic Mass Growth in Patients with Traumatic Brain Injury

Effect of Tranexamic Acid on Prevention of Hemorrhagic Mass Growth in Patients with Traumatic Brain Injury
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DOI:
10.1016/j.wneu.2017.10.075
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发表时间:
2018-01-01
期刊:
影响因子:
2
通讯作者:
Atoof, Fatemeh
Atoof, Fatemeh
中科院分区:
医学4区
文献类型:
--
作者:
Fakharian, Esmaeil;Abedzadeh-Kalahroudi, Masoumeh;Atoof, Fatemeh

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背景:颅内出血是创伤性脑损伤的常见并发症。本研究的目的是评价氨甲环酸(TXA)对颅脑损伤患者出血性肿块生长的影响。方法和方法:在这项随机、双盲的临床试验中,149名接受CT扫描的脑外伤患者随机分配接受TXA或安慰剂治疗。24小时后,再次进行CT扫描,以评估出血、新出血的变化以及血液对脑组织的质量影响。主要结果是出血性病变的增长。数据用SPSS软件进行Fisher Exact、卡方和Mann-Whitney U检验,以及线性和Logistic回归模型。FINDINGS:TXA组和安慰剂组出血病变增长的发生率分别为20.5%和22.7%。差异无统计学意义(P=0.87,RR=0.89)。血栓素A组出血灶生长的平均(标准差)为9.4(15.3),安慰剂组为10.2(10.1),差异无统计学意义(P=0.27)。TXA组的死亡率(2.7%比4.%)、出院时的不良结局(10.8%比17.3%)和3个月后(6.8%比14.7%)低于安慰剂组,但差异不具有统计学意义。结论:小剂量应用TXA不能明显阻止创伤后出血灶的生长,也不能改善临床预后。
BACKGROUND: Intracranial hemorrhage is a common complication of traumatic brain injury (TBI). The purpose of this study is evaluation of the effect of tranexamic acid (TXA) on hemorrhagic mass growth in TBI patients.PATIENTS AND METHODS: In this randomized, doubleblind clinical trial, 149 patients with TBI and any kind of blood on their computed tomography scan enrolled in the study and were randomly allocated to receive TXA or placebo. After 24 hours, computed tomography scan was repeated for assessing the changes in hemorrhage, new bleeding, and mass effects of blood on brain tissue. The primary outcome was growth of the hemorrhagic lesion. Data were analyzed by SPSS software using Fisher exact, chi-square, and Mann-Whitney U tests, as well as linear and logistic regression models.FINDINGS: The incidence of hemorrhagic lesion growth was 20.5% in the TXA group and 22.7% in the placebo group. The difference was not significant (P = 0.87, RR = 0.89). The mean (standard deviation) of hemorrhagic lesion growth was 9.4 (15.3) in the TXA group and 10.2 (10.1) in the placebo group without significant difference (P =d 0.27). The frequency of deaths (2.7% vs. 4%), adverse outcome at discharge (10.8% vs. 17.3%), and 3 months later (6.8% vs. 14.7%) in the TXA group were lower than the placebo, but the difference was not statistically significant. No side effect was observed with the administration of TXA.CONCLUSION: Administration of a short dose of TXA does not lead to significant prevention of growth of posttraumatic hemorrhagic lesion or improvement of clinical outcomes.