Sterility of Tranexamic Acid Syringes Prefilled by Tactical Combat Medics in a Garrison Setting.

Q3 Medicine
Janelle Sourbeer, Aaron Yallowitz, Gregory J Zarow, Keri E Garcia, David S Allen, Alexander Iteen, Andrew J McGowan, Theodore C Morrison, Matthew A Tovar, Eric F Sulava, William D Bianchi
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Abstract

Background: Tranexamic acid (TXA) is an antifibrinolytic agent that confers a significant mortality benefit in the treatment of hemorrhagic trauma. The benefit of TXA is timedependent; Special Operations Tactical Medics (SOTM) and Special Operations Independent Duty Corpsmen (SOIDC) commonly prefill TXA syringes prior to a mission. However, the sterility of prefilled TXA syringes remains unclear.

Methods: SOTMs (n=40) and SOIDCs (n=11) each filled two syringes with TXA in a garrison-type training setting using their customary preparation technique. As controls, a trained clinical research coordinator (CRC) filled 51 TXA syringes in the garrison setting and 51 in a Level-II Biosafety Lab (n=204 syringes total). In all cases, TXA was drawn from a glass vial into a 10cc syringe. TXA syringes were stored at room temperature, plated on chocolate agar at 0-, 3-, 6-, and 9-day intervals from collection (n=816 plates total), incubated for 7 days, then observed for bacterial growth.

Results: The observed positivity rate of 0.6% (5 of 816 plates) was statistically similar to the published false positive rate of 0.5% for chocolate agar (P=.68). Positivity rates did not significantly differ by garrison setting versus lab setting (P=.20), SOTM/SOIDC versus CRC (P=.18), or day of testing (P=.26). One TXA syringe demonstrated contamination on Day 9.

Conclusion: Present findings suggest that TXA syringes prepared in a simulated operational environment can maintain sterility up to 6 days when stored at room temperature. These results directly inform the Committee on Tactical Combat Casualty Care (CoTCCC) regarding the safe storage duration of prefilled TXA syringes.

战术战斗医务人员在驻军环境中预先填充氨甲环酸注射器的无菌性。
背景:氨甲环酸(TXA)是一种抗纤溶药物,在治疗出血性创伤中具有显著的死亡率优势。TXA的益处是有时间依赖性的;特种作战战术医务人员(SOTM)和特种作战独立值班医务人员(SOIDC)通常在执行任务之前预先填充TXA注射器。然而,预充TXA注射器的无菌性尚不清楚。方法:40名SOTMs (n=40)和11名SOIDCs (n=11)在驻防式训练环境中按其习惯制备技术分别向2支注射器中填充TXA。作为对照,一名训练有素的临床研究协调员(CRC)在驻地环境中填充了51支TXA注射器,在二级生物安全实验室中填充了51支(总共204支注射器)。在所有病例中,从玻璃小瓶中抽取血凝素到10cc注射器中。TXA注射器在室温下保存,收集后每隔0、3、6、9天(共816个板)分别镀于巧克力琼脂上,孵育7天,观察细菌生长情况。结果:观察到的阳性率为0.6%(816个平板中有5个),与已发表的巧克力琼脂假阳性率0.5% (P= 0.68)具有统计学意义。驻军环境与实验室环境(P= 0.20)、SOTM/SOIDC与CRC (P= 0.18)或检测天数(P= 0.26)的阳性率无显著差异。一个TXA注射器在第9天被污染。结论:本研究结果表明,在模拟操作环境中制备的TXA注射器在室温下保存可保持长达6天的无菌性。这些结果直接通知战术战斗伤亡护理委员会(CoTCCC)关于预充TXA注射器的安全储存时间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.30
自引率
0.00%
发文量
91
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