Moore Ernest E, Michelson Edward A, Gabriel-Ramos Katrina, Cripps Michael W, Flores Antolin, Vandyck Kofi, Thurston Brian, Brennan Meghan, Viola Francesco, Winegar Deborah A
Ernest E Moore Shock Trauma Center, Denver Health Medical Center, Denver, Colorado, USA.
Emergency Medicine, Texas Tech University Health Sciences Center El Paso, El Paso, Texas, USA.
Trauma Surg Acute Care Open. 2025 Jun 3;10(2):e001672. doi: 10.1136/tsaco-2024-001672. eCollection 2025.
Trauma-induced coagulopathy (TIC) occurs in a quarter of trauma patients and is associated with death due to uncontrolled bleeding. Current guidelines recommend viscoelastic testing (VET) to assess coagulopathy and guide transfusions. The Quantra with the QStat Cartridge is a point-of-care (POC) VET device that measures changes in clot stiffness (CS) during coagulation and fibrinolysis using ultrasound detection of resonance. This study aimed to evaluate the performance of the QStat Cartridge in trauma patients compared with rotational thromboelastometry (ROTEM) and thromboelastography (TEG) 6s VET devices.
A multicenter prospective observational study was conducted in adult patients meeting criteria for a full trauma team response at eight US level 1 trauma centers. Citrated blood samples drawn on arrival at the hospital or after blood transfusions were analyzed in parallel on QStat, ROTEM or TEG. Correlation between QStat and equivalent VET measurements was assessed by linear regression. Concordance was assessed by agreement of results relative to device-specific normal reference ranges.
259 severely injured patients were enrolled, yielding 271 samples for analysis. Moderate to strong correlations between QStat and corresponding ROTEM and TEG measurements were observed (r=0.64-0.88). The concordance between CS results was 84.5% for QStat CS and EXTEM A10 and 83.3% for CS and citrated rapid TEG maximum amplitude. For fibrinogen-related results, concordance was 81.5% for QStat fibrinogen contribution to clot stiffness (FCS) and FIBTEM A10 and 93.8% for FCS and citrated functional fibrinogen maximum amplitude. For fibrinolysis measurements, the overall agreement between QStat clot stability to lysis and EXTEM ML or CK-LY30 was 97.5% and 92.9%, respectively.
QStat provides comparable information to the ROTEM and TEG 6s in trauma patients and can be useful for diagnosing TIC and guiding treatment. The Quantra's simplicity of use, ability to deploy at the POC, and rapid availability of results may provide clinicians with a faster, more convenient means to assess and manage TIC.
Diagnostic test, level II.
NCT04312958.
创伤性凝血病（TIC）发生于四分之一的创伤患者中，与因出血无法控制导致的死亡相关。当前指南推荐使用粘弹性检测（VET）来评估凝血病并指导输血。配备QStat检测盒的Quantra是一种即时检验（POC）VET设备，其利用超声共振检测来测量凝血和纤溶过程中血凝块硬度（CS）的变化。本研究旨在评估QStat检测盒与旋转血栓弹力图（ROTEM）和血栓弹力描记法（TEG）6s VET设备相比在创伤患者中的性能。
在美国8家一级创伤中心，对符合全面创伤团队响应标准的成年患者进行了一项多中心前瞻性观察研究。在患者入院时或输血后采集的枸橼酸盐抗凝血样本，同时在QStat、ROTEM或TEG上进行分析。通过线性回归评估QStat与等效VET测量值之间的相关性。通过相对于设备特定正常参考范围的结果一致性来评估一致性。
纳入259例重伤患者，共获得271份样本用于分析。观察到QStat与相应的ROTEM和TEG测量值之间存在中度至强相关性（r = 0.64 - 0.88）。对于CS结果，QStat CS与EXTEM A10之间的一致性为84.5%，CS与枸橼酸盐快速TEG最大振幅之间的一致性为83.3%。对于纤维蛋白原相关结果，QStat纤维蛋白原对血凝块硬度的贡献（FCS）与FIBTEM A10之间的一致性为81.5%，FCS与枸橼酸盐功能性纤维蛋白原最大振幅之间的一致性为93.8%。对于纤溶测量，QStat血凝块溶解稳定性与EXTEM ML或CK - LY30之间的总体一致性分别为97.5%和92.9%。
QStat在创伤患者中提供与ROTEM和TEG 6s相当的信息，可用于诊断TIC和指导治疗。Quantra使用简便、能够在POC处部署且结果快速可得，可能为临床医生提供一种更快、更便捷的手段来评估和管理TIC。
诊断试验，二级。
NCT04312958。
