Department of Surgery, University of Pittsburgh, Pittsburgh, PA.
Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA.
Ann Surg. 2021 Sep 1;274(3):419-426. doi: 10.1097/SLA.0000000000005002.
We sought to characterize the timing of administration of prehospital tranexamic acid (TXA) and associated outcome benefits.
TXA has been shown to be safe in the prehospital setting post-injury.
We performed a secondary analysis of a recent prehospital randomized TXA clinical trial in injured patients. Those who received prehospital TXA within 1 hour (EARLY) from time of injury were compared to those who received prehospital TXA beyond 1 hour (DELAYED). We included patients with a shock index of >0.9. Primary outcome was 30-day mortality. Kaplan-Meier and Cox Hazard regression were utilized to characterize mortality relationships.
EARLY and DELAYED patients had similar demographics, injury characteristics, and shock severity but DELAYED patients had greater prehospital resuscitation requirements and longer prehospital times. Stratified Kaplan-Meier analysis demonstrated significant separation for EARLY patients (N = 238, log-rank chi-square test, 4.99; P = 0.03) with no separation for DELAYED patients (N = 238, log-rank chi-square test, 0.04; P = 0.83). Stratified Cox Hazard regression verified, after controlling for confounders, that EARLY TXA was associated with a 65% lower independent hazard for 30-day mortality [hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.19-0.65, P = 0.001] with no independent survival benefit found in DELAYED patients (HR 1.00, 95% CI 0.63-1.60, P = 0.999). EARLY TXA patients had lower incidence of multiple organ failure and 6-hour and 24-hour transfusion requirements compared to placebo.
Administration of prehospital TXA within 1 hour from injury in patients at risk of hemorrhage is associated with 30-day survival benefit, lower incidence of multiple organ failure, and lower transfusion requirements.
我们旨在描述创伤后院前使用氨甲环酸(TXA)的时间及相关获益情况。
TXA 在创伤后院前环境中已被证实是安全的。
我们对最近一项创伤患者院前使用氨甲环酸的随机临床试验进行了二次分析。将受伤后 1 小时内(早期)接受院前 TXA 的患者与超过 1 小时(延迟)接受院前 TXA 的患者进行比较。我们纳入了休克指数>0.9 的患者。主要结局为 30 天死亡率。采用 Kaplan-Meier 和 Cox 风险回归来描述死亡率的关系。
早期和延迟组患者的人口统计学、损伤特征和休克严重程度相似,但延迟组患者需要更多的院前复苏和更长的院前时间。分层 Kaplan-Meier 分析显示,早期患者(N=238,对数秩检验,4.99;P=0.03)有显著分离,而延迟患者(N=238,对数秩检验,0.04;P=0.83)没有分离。分层 Cox 风险回归证实,在校正混杂因素后,早期 TXA 与 30 天死亡率的独立风险降低 65%相关[风险比(HR)0.35,95%置信区间(CI)0.19-0.65,P=0.001],而延迟组患者则未发现独立的生存获益(HR 1.00,95%CI 0.63-1.60,P=0.999)。与安慰剂相比,早期 TXA 组患者的多器官衰竭发生率、6 小时和 24 小时输血需求均较低。
在有出血风险的患者中,受伤后 1 小时内给予院前 TXA 与 30 天生存获益、较低的多器官衰竭发生率和较低的输血需求相关。