Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran.
Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran.
World Neurosurg. 2018 Jan;109:e748-e753. doi: 10.1016/j.wneu.2017.10.075. Epub 2017 Oct 23.
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.
In this randomized, double-blind 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.
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 = 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.
Administration of a short dose of TXA does not lead to significant prevention of growth of posttraumatic hemorrhagic lesion or improvement of clinical outcomes.
颅内出血是创伤性脑损伤（TBI）的常见并发症。本研究旨在评估氨甲环酸（TXA）对 TBI 患者出血性肿块生长的影响。
在这项随机、双盲临床试验中，纳入了 149 名 TBI 患者，他们的计算机断层扫描（CT）上有任何类型的血液，并将其随机分配接受 TXA 或安慰剂治疗。24 小时后，再次进行 CT 扫描，以评估出血、新出血和血液对脑组织的占位效应的变化。主要结局是出血性病变的生长。使用 Fisher 确切检验、卡方检验和 Mann-Whitney U 检验，以及线性和逻辑回归模型，对 SPSS 软件中的数据进行分析。
TXA 组的出血性病变生长发生率为 20.5%，安慰剂组为 22.7%。差异无统计学意义（P=0.87，RR=0.89）。TXA 组出血性病变生长的平均值（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% vs. 4%）、出院时不良结局（10.8% vs. 17.3%）和 3 个月后（6.8% vs. 14.7%）的频率低于安慰剂组，但差异无统计学意义。TXA 给药未观察到不良反应。
给予短剂量的 TXA 并不能显著预防创伤后出血性病变的生长或改善临床结局。
