Abstract：
OBJECTIVE: To describe the relationships between different methods of measuring functional fibrinogen levels in severely injured, bleeding trauma patients across multiple timepoints during hospitalisation.
METHODS: In 100 adult trauma patients enrolled in the FEISTY pilot randomised clinical trial at four tertiary trauma centres in Australia, blood samples were collected prospectively. Consistency of agreement was calculated, comparing functional fibrinogen levels measured by four methods - ROTEM® Delta and Sigma FIBTEM A5, TEG® 6s CFF MA, and gold-standard Clauss Fibrinogen.
RESULTS: Comparing the ROTEM® Delta and new-generation ROTEM® Sigma machine, consistency of agreement for FIBTEM A5, measured by calculating intraclass correlation coefficients (ICCs), was ≥0.73 across all analysed timepoints, with mean differences (Sigma minus Delta) of 0.10-3.57 mm. Corresponding values comparing the ROTEM® Sigma FIBTEM A5 and TEG® 6s CFF MA were ICC = 0.55-0.82 and ICC = 4.69-7.97 (CFF MA minus A5). Comparing ROTEM® Sigma FIBTEM A5 and Clauss Fibrinogen Analysis (CFA), among statistically significant simple linear regression models, R2 was 0.25-0.67, and comparing TEG® 6s CFF MA and CFA (CFA) 0.65-0.82, although not all differences were significant with the latter comparison. Relationships across all timepoints combined were Clauss Fibrinogen (CF) (g/L) = 0.21𝑥 + 0.004 (where 𝑥 = ROTEM® Sigma FIBTEM A5 in mm) and (g/L) = 0.16𝑥 - 0.06 (where 𝑥 = TEG® 6s CFF MA in mm).
CONCLUSIONS: The present study revealed acceptable agreement between four different assays measuring functional fibrinogen, with current- and previous-generation ROTEM® machines (Sigma, Delta) performing similarly measuring functional fibrinogen via FIBTEM assay. This suggests that haemostatic resuscitation algorithms designed for the ROTEM® Delta can be applied to the ROTEM® Sigma to guide fibrinogen replacement.
METHODS: In 100 adult trauma patients enrolled in the FEISTY pilot randomised clinical trial at four tertiary trauma centres in Australia, blood samples were collected prospectively. Consistency of agreement was calculated, comparing functional fibrinogen levels measured by four methods - ROTEM® Delta and Sigma FIBTEM A5, TEG® 6s CFF MA, and gold-standard Clauss Fibrinogen.
RESULTS: Comparing the ROTEM® Delta and new-generation ROTEM® Sigma machine, consistency of agreement for FIBTEM A5, measured by calculating intraclass correlation coefficients (ICCs), was ≥0.73 across all analysed timepoints, with mean differences (Sigma minus Delta) of 0.10-3.57 mm. Corresponding values comparing the ROTEM® Sigma FIBTEM A5 and TEG® 6s CFF MA were ICC = 0.55-0.82 and ICC = 4.69-7.97 (CFF MA minus A5). Comparing ROTEM® Sigma FIBTEM A5 and Clauss Fibrinogen Analysis (CFA), among statistically significant simple linear regression models, R2 was 0.25-0.67, and comparing TEG® 6s CFF MA and CFA (CFA) 0.65-0.82, although not all differences were significant with the latter comparison. Relationships across all timepoints combined were Clauss Fibrinogen (CF) (g/L) = 0.21𝑥 + 0.004 (where 𝑥 = ROTEM® Sigma FIBTEM A5 in mm) and (g/L) = 0.16𝑥 - 0.06 (where 𝑥 = TEG® 6s CFF MA in mm).
CONCLUSIONS: The present study revealed acceptable agreement between four different assays measuring functional fibrinogen, with current- and previous-generation ROTEM® machines (Sigma, Delta) performing similarly measuring functional fibrinogen via FIBTEM assay. This suggests that haemostatic resuscitation algorithms designed for the ROTEM® Delta can be applied to the ROTEM® Sigma to guide fibrinogen replacement.
摘要：
目的：描述严重损伤中测量功能性纤维蛋白原水平的不同方法之间的关系，住院期间多个时间点的出血创伤患者。
方法：在澳大利亚四个三级创伤中心参加FEISTY试点随机临床试验的100名成年创伤患者中，我们前瞻性地收集了血液样本.计算了协议的一致性，比较通过四种方法测量的功能性纤维蛋白原水平-ROTEM®Delta和SigmaFIBTEMA5，TEG®6sCFFMA，和黄金标准的Clauss纤维蛋白原。
结果：比较ROTEM®Delta和新一代ROTEM®Sigma机器，FIBTEMA5的一致性，通过计算组内相关系数(ICC)来衡量，在所有分析的时间点上≥0.73，平均差(Sigma减去Delta)为0.10-3.57毫米。比较ROTEM®SigmaFIBTEMA5和TEG®6sCFFMA的相应值是ICC=0.55-0.82和ICC=4.69-7.97(CFFMA减去A5)。比较ROTEM®SigmaFIBTEMA5和Clauss纤维蛋白原分析（CFA），在统计显著的简单线性回归模型中，R2为0.25-0.67，比较TEG®6sCFFMA和CFA（CFA）0.65-0.82，尽管并非所有差异都与后者比较显着。所有时间点之间的关系为Clauss纤维蛋白原（CF）（g/L）=0.21？0.004（其中？=ROTEM®SigmaFIBTEMA5，以mm为单位）和（g/L）=0.16？-0.06（其中？=TEG®6sCFFMA，以mm为单位）。
结论：本研究揭示了四种不同的测定功能性纤维蛋白原的一致性，与当前和上一代ROTEM®机器(Sigma，Delta）通过FIBTEM测定类似地测量功能性纤维蛋白原。这表明为ROTEM®Delta设计的止血复苏算法可以应用于ROTEM®Sigma以指导纤维蛋白原替换。
方法：在澳大利亚四个三级创伤中心参加FEISTY试点随机临床试验的100名成年创伤患者中，我们前瞻性地收集了血液样本.计算了协议的一致性，比较通过四种方法测量的功能性纤维蛋白原水平-ROTEM®Delta和SigmaFIBTEMA5，TEG®6sCFFMA，和黄金标准的Clauss纤维蛋白原。
结果：比较ROTEM®Delta和新一代ROTEM®Sigma机器，FIBTEMA5的一致性，通过计算组内相关系数(ICC)来衡量，在所有分析的时间点上≥0.73，平均差(Sigma减去Delta)为0.10-3.57毫米。比较ROTEM®SigmaFIBTEMA5和TEG®6sCFFMA的相应值是ICC=0.55-0.82和ICC=4.69-7.97(CFFMA减去A5)。比较ROTEM®SigmaFIBTEMA5和Clauss纤维蛋白原分析（CFA），在统计显著的简单线性回归模型中，R2为0.25-0.67，比较TEG®6sCFFMA和CFA（CFA）0.65-0.82，尽管并非所有差异都与后者比较显着。所有时间点之间的关系为Clauss纤维蛋白原（CF）（g/L）=0.21？0.004（其中？=ROTEM®SigmaFIBTEMA5，以mm为单位）和（g/L）=0.16？-0.06（其中？=TEG®6sCFFMA，以mm为单位）。
结论：本研究揭示了四种不同的测定功能性纤维蛋白原的一致性，与当前和上一代ROTEM®机器(Sigma，Delta）通过FIBTEM测定类似地测量功能性纤维蛋白原。这表明为ROTEM®Delta设计的止血复苏算法可以应用于ROTEM®Sigma以指导纤维蛋白原替换。
