Arrowhead Regional Medical Center, Department of Emergency Medicine, Colton, California.
California University of Sciences and Medicine, Colton, California.
West J Emerg Med. 2018 Nov;19(6):977-986. doi: 10.5811/westjem.2018.8.39336. Epub 2018 Sep 10.
Hemorrhage is one of the leading causes of death in trauma victims. Historically, paramedics have not had access to medications that specifically target the reversal of trauma-induced coagulopathies. The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the safety and efficacy of tranexamic acid (TXA) use in the civilian prehospital setting in cases of traumatic hemorrhagic shock.
The Cal-PAT study is a multi-centered, prospective, observational cohort study with a retrospective comparison. From March 2015 to July 2017, patients ≥ 18 years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified by first responders in the prehospital setting were considered for TXA treatment. A control group was formed of patients seen in the five years prior to data collection cessation (June 2012 to July 2017) at each receiving center who were not administered TXA. Control group patients were selected through propensity score matching based on gender, age, Injury Severity Scores, and mechanism of injury. The primary outcome assessed was mortality recorded at 24 hours, 48 hours, and 28 days. Additional variables assessed included total blood products transfused, the hospital and intensive care unit length of stay, systolic blood pressure taken prior to TXA administration, Glasgow Coma Score observed prior to TXA administration, and the incidence of known adverse events associated with TXA administration.
We included 724 patients in the final analysis, with 362 patients in the TXA group and 362 in the control group. Reduced mortality was noted at 28 days in the TXA group in comparison to the control group (3.6% vs. 8.3% for TXA and control, respectively, odds ratio [OR]=0.41 with 95% confidence interval [CI] [0.21 to 0.8]). This mortality difference was greatest in severely injured patients with ISS >15 (6% vs 14.5% for TXA and control, respectively, OR=0.37 with 95% CI [0.17 to 0.8]). Furthermore, a significant reduction in total blood product transfused was observed after TXA administration in the total cohort as well as in severely injured patients. No significant increase in known adverse events following TXA administration were observed.
Findings from the Cal-PAT study suggest that TXA use in the civilian prehospital setting may safely improve survival outcomes in patients who have sustained traumatic injury with signs of hemorrhagic shock.
出血是创伤患者死亡的主要原因之一。历史上,护理人员无法使用专门针对创伤引起的凝血功能障碍逆转的药物。加利福尼亚院前抗纤维蛋白溶解疗法(Cal-PAT)研究旨在评估在民用院前环境中使用氨甲环酸(TXA)治疗创伤性失血性休克的安全性和疗效。
Cal-PAT 研究是一项多中心、前瞻性、观察性队列研究,具有回顾性比较。从 2015 年 3 月至 2017 年 7 月,在院前环境中,由急救人员识别出有出血性休克迹象的≥18 岁的钝器或穿透性创伤患者被认为适合 TXA 治疗。对照组由在数据收集截止前五年(2012 年 6 月至 2017 年 7 月)在每个接受中心就诊且未接受 TXA 治疗的患者组成。对照组患者通过基于性别、年龄、损伤严重程度评分和损伤机制的倾向评分匹配选择。主要评估结果是 24 小时、48 小时和 28 天记录的死亡率。评估的其他变量包括输注的总血制品、医院和重症监护病房的住院时间、TXA 给药前的收缩压、TXA 给药前观察到的格拉斯哥昏迷评分,以及与 TXA 给药相关的已知不良事件的发生率。
我们最终分析了 724 名患者,其中 TXA 组 362 名,对照组 362 名。与对照组相比,TXA 组在 28 天时的死亡率降低(TXA 组为 3.6%,对照组为 8.3%,优势比[OR]=0.41,95%置信区间[CI]为 [0.21 至 0.8])。这种死亡率差异在损伤严重程度评分(ISS)>15 的患者中最大(TXA 组为 6%,对照组为 14.5%,OR=0.37,95%CI[0.17 至 0.8])。此外,在整个队列以及严重损伤患者中,TXA 给药后总血制品输注量显著减少。未观察到 TXA 给药后已知不良事件的显著增加。
Cal-PAT 研究的结果表明,在民用院前环境中使用 TXA 可能安全地提高有出血性休克迹象的创伤患者的生存结果。