Neeki Michael M, Dong Fanglong, Toy Jake, Salameh Joseph, Rabiei Massoud, Powell Joe, Vara Richard, Inaba Kenji, Wong David, Comunale Mark E, Lowe Andrew, Chandwani Deepak, Quispe Juan, Borger Rodney
Arrowhead Regional Medical Center, Department of Emergency Medicine, Colton, California.
California University of Science and Medicine, Colton, California.
West J Emerg Med. 2020 Feb 21;21(2):217-225. doi: 10.5811/westjem.2019.10.43055.
Patients with trauma-induced coagulopathies may benefit from the use of antifibrinolytic agents, such as tranexamic acid (TXA). This study evaluated the safety and efficacy of TXA in civilian adults hospitalized with traumatic hemorrhagic shock.
Patients who sustained blunt or penetrating trauma with signs of hemorrhagic shock from June 2014 through July 2018 were considered for TXA treatment. A retrospective control group was formed from patients seen in the same past five years who were not administered TXA and matched based on age, gender, Injury Severity Score (ISS), and mechanism of injury (blunt vs penetrating trauma). The primary outcome of this study was mortality measured at 24 hours, 48 hours, and 28 days. Secondary outcomes included total blood products transfused, hospital length of stay (LOS), intensive care unit LOS, and adverse events. We conducted three pre-specified subgroup analyses to assess outcomes of patients, including (1) those who were severely injured (ISS >15), (2) those who sustained significant blood loss (≥10 units of total blood products transfused), and (3) those who sustained blunt vs penetrating trauma.
Propensity matching yielded two cohorts: the hospital TXA group (n = 280) and a control group (n = 280). The hospital TXA group had statistically lower mortality at 28 days (1.1% vs 5%, odds ratio [OR] [0.21], (95% confidence interval [CI], 0.06, 0.72)) and used fewer units of blood products (median = 4 units, interquartile range (IQR) = [1, 10] vs median=7 units, IQR = [2, 12.5] for the hospital TXA and control groups, respectively, (95% CI for the difference in median, -3 to -1). There were no statistically significant differences between groups with regard to 24-hour mortality (1.1% vs 1.1%, OR = 1, 95% CI, 0.20, 5.00), 48-hour mortality (1.1% vs 1.4%, OR [0.74], 95% CI, 0.17, 3.37), hospital LOS (median= 9 days, IQR = (5, 16) vs median =12 days IQR = (6, 22.5) for the hospital TXA and control groups, respectively, 95% CI for the difference in median = (-5 to 0)), and incidence of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism) during hospital stay (0.7% vs 0.7% for the hospital TXA and control group, respectively, OR [1], 95% CI, 0.14 to 7.15). We conducted subgroup analyses on patients with ISS>15, patients transfused with ≥10 units of blood products, and blunt vs penetrating trauma. The results indicated lower 28-day mortality for ISS>15 (1.8% vs 7.1%, OR [0.23], 95% CI, 0.06 to 0.81) and blunt trauma (0.6% vs 6.3%, OR [0.09], 95% CI, 0.01 to 0.75); fewer units of blood products for penetrating trauma (median = 2 units, IQR = (1, 8) vs median = 8 units, IQR = (5, 15) for the hospital TXA and control groups, respectively, 95% CI for the difference in median = (-6 to -3)), and ISS>15 (median = 7 units, IQR = (2, 14) vs median = 8.5 units, IQR = (4, 16) for the hospital TXA and control groups, respectively, 95% CI for the difference in median, -3 to 0).
The current study demonstrates a statistically significant reduction in mortality after TXA administration at 28 days, but not at 24 and 48 hours, in patients with traumatic hemorrhagic shock.
创伤性凝血病患者可能受益于使用抗纤维蛋白溶解剂，如氨甲环酸（TXA）。本研究评估了TXA在因创伤性失血性休克住院的成年平民中的安全性和有效性。
2014年6月至2018年7月期间遭受钝性或穿透性创伤并有失血性休克体征的患者被考虑接受TXA治疗。回顾性对照组由过去五年中未接受TXA治疗的患者组成，并根据年龄、性别、损伤严重程度评分（ISS）和损伤机制（钝性伤与穿透性创伤）进行匹配。本研究的主要结局是在24小时、48小时和28天时测量的死亡率。次要结局包括输注的血液制品总量、住院时间（LOS）、重症监护病房住院时间以及不良事件。我们进行了三项预先设定的亚组分析，以评估患者的结局，包括（1）重伤患者（ISS>15），（2）失血量大的患者（输注的血液制品总量≥10单位），以及（3）钝性伤与穿透性创伤患者。
倾向评分匹配产生了两个队列：医院TXA组（n = 280）和对照组（n = 280）。医院TXA组在28天时的死亡率在统计学上较低（1.1%对5%，优势比[OR][0.21]，（95%置信区间[CI]，0.06，0.72）），并且使用的血液制品单位较少（中位数 = 4单位，四分位数间距（IQR） = [1, 10]，而医院TXA组和对照组分别为中位数 = 7单位，IQR = [2, 12.5]，（中位数差异的95%CI，-3至-1））。两组在24小时死亡率（1.1%对1.1%，OR = 1，95%CI，0.20，5.00）、48小时死亡率（1.1%对1.4%，OR[0.74]，95%CI，0.17，3.37）、住院LOS（医院TXA组和对照组分别为中位数 = 9天，IQR = （5, 16）对中位数 = 12天，IQR = （6, 22.5），中位数差异的95%CI = （-5至0））以及住院期间血栓栓塞事件（如深静脉血栓形成、肺栓塞）的发生率（医院TXA组和对照组分别为0.7%对0.7%，OR[1]，95%CI，0.14至7.15）方面没有统计学上的显著差异。我们对ISS>15的患者、输注≥10单位血液制品的患者以及钝性伤与穿透性创伤患者进行了亚组分析。结果表明，ISS>15的患者28天死亡率较低（1.8%对7.1%，OR[0.23]，95%CI，0.06至0.81），钝性伤患者死亡率较低（0.6%对6.3%，OR[0.09]，95%CI，0.01至0.75）；穿透性创伤患者使用的血液制品单位较少（医院TXA组和对照组分别为中位数 = 2单位，IQR = （1, 8）对中位数 = 8单位，IQR = （5, 15），中位数差异的95%CI = （-6至-3）），ISS>15的患者也较少（医院TXA组和对照组分别为中位数 = 7单位，IQR = （2, 14）对中位数 = 8.5单位，IQR = （4, 16），中位数差异的95%CI，-3至0）。
本研究表明，对于创伤性失血性休克患者，在28天时给予TXA后死亡率在统计学上有显著降低，但在24小时和48小时时没有。
