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氨甲环酸是否会增加创伤患者的静脉血栓栓塞风险?一项跨越 17 家一级创伤中心的前瞻性多中心分析。

Does tranexamic acid increase venous thromboembolism risk among trauma patients? A prospective multicenter analysis across 17 level I trauma centers.

机构信息

Department of Surgery, Stanford University School of Medicine, Stanford, CA, United States; Stanford-Surgery Policy Improvement Research and Education Center (S-SPIRE), United States.

Stanford-Surgery Policy Improvement Research and Education Center (S-SPIRE), United States.

出版信息

Injury. 2023 Nov;54(11):111008. doi: 10.1016/j.injury.2023.111008. Epub 2023 Aug 23.

DOI:10.1016/j.injury.2023.111008
PMID:37669883
Abstract

IMPORTANCE

The early use of tranexamic acid (TXA) has demonstrated benefit among some trauma patients in hemorrhagic shock. The association between TXA administration and thromboembolic events (including deep vein thrombosis (DVT), pulmonary embolism (PE) and pulmonary thrombosis (PT)) remains unclear. We aimed to characterize the risk of venous thromboembolism (VTE) subtypes among trauma patients receiving TXA and to determine whether TXA is associated with VTE risk and mortality.

METHODS

We analyzed a prospective, observational, multicenter cohort data from the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study group. The study was conducted across 17 US level I trauma centers between January 1, 2018, and December 31,2020. We studied trauma patients ages 18-40 years, admitted for at least 48 h with a minimum of 1 VTE risk factor and followed until hospital discharge or 30 days. We compared TXA recipients to non-recipients for VTE and mortality using inverse probability weighted Cox models. The primary outcome was the presence of documented venous thromboembolism (VTE). The secondary outcome was mortality. VTE was defined as DVT, PE, or PT.

RESULTS

Among the 7,331 trauma patients analyzed, 466 (6.4%) received TXA. Patients in the TXA group were more severely injured than patients in the non-TXA group (ISS 16+: 69.1% vs. 48.5%, p < 0.001) and a higher percentage underwent a major surgical procedure (85.8% vs. 73.6%, p < 0.001). Among TXA recipients, 12.5% developed VTE (1.3% PT, 2.4% PE, 8.8% DVT) with 5.6% mortality. In the non-TXA group, 4.6% developed VTE (1.1% PT, 0.5% PE, 3.0% DVT) with 1.7% mortality. In analyses adjusting for patient demographic and clinical characteristics, TXA administration was not significantly associated with VTE (aHR 1.00, 95%CI: 0.69-1.46, p = 0.99) but was significantly associated with increased mortality (aHR 2.01, 95%CI: 1.46-2.77, p < 0.001).

CONCLUSION

TXA was not clearly identified as an independent risk factor for VTE in adjusted analyses, but the risk of VTE among trauma patients receiving TXA remains high (12.5%). This supports the judicious use of TXA in resuscitation, with consideration of early initiation of DVT prophylaxis in this high-risk group.

摘要

重要性:在出血性休克的某些创伤患者中,早期使用氨甲环酸(TXA)已显示出益处。TXA 给药与血栓栓塞事件(包括深静脉血栓形成(DVT)、肺栓塞(PE)和肺血栓形成(PT))之间的关联仍不清楚。我们旨在描述接受 TXA 的创伤患者中静脉血栓栓塞(VTE)亚型的风险,并确定 TXA 是否与 VTE 风险和死亡率相关。

方法:我们分析了来自创伤性血栓栓塞研究领袖联盟(CLOTT)研究组的前瞻性、观察性、多中心队列数据。该研究于 2018 年 1 月 1 日至 2020 年 12 月 31 日在 17 家美国一级创伤中心进行。我们研究了年龄在 18-40 岁之间的创伤患者,至少住院 48 小时,至少有 1 个 VTE 危险因素,并随访至出院或 30 天。我们使用逆概率加权 Cox 模型比较 TXA 接受者和非接受者的 VTE 和死亡率。主要结局是存在有记录的静脉血栓栓塞(VTE)。次要结局是死亡率。VTE 定义为 DVT、PE 或 PT。

结果:在分析的 7331 名创伤患者中,466 名(6.4%)接受了 TXA。TXA 组的患者比非 TXA 组的患者受伤更严重(ISS 16+:69.1% vs. 48.5%,p<0.001),并且更多的患者接受了主要手术(85.8% vs. 73.6%,p<0.001)。在 TXA 接受者中,12.5%发生 VTE(1.3%PT、2.4%PE、8.8%DVT),死亡率为 5.6%。在非 TXA 组中,4.6%发生 VTE(1.1%PT、0.5%PE、3.0%DVT),死亡率为 1.7%。在调整患者人口统计学和临床特征的分析中,TXA 给药与 VTE 无显著相关性(调整后的危险比 1.00,95%CI:0.69-1.46,p=0.99),但与死亡率增加显著相关(调整后的危险比 2.01,95%CI:1.46-2.77,p<0.001)。

结论:在调整后的分析中,TXA 并未明确被确定为 VTE 的独立危险因素,但接受 TXA 的创伤患者发生 VTE 的风险仍然很高(12.5%)。这支持在复苏中谨慎使用 TXA,并考虑在这个高风险人群中早期开始 DVT 预防。

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