Intensive Care Unit, Rockhampton Hospital, Rockhampton, Queensland, Australia.
Intensive Care Unit, Gold Coast University Hospital, Gold Coast, Queensland, Australia.
Emerg Med Australas. 2024 Jun;36(3):363-370. doi: 10.1111/1742-6723.14356. Epub 2024 Jan 9.
To describe the relationships between different methods of measuring functional fibrinogen levels in severely injured, bleeding trauma patients across multiple timepoints during hospitalisation.
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.
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, R 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).
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.
描述在住院期间的多个时间点，对严重创伤、出血的创伤患者，使用不同方法测量功能性纤维蛋白原水平之间的关系。
在澳大利亚 4 家三级创伤中心的 FEISTY 试验中，对 100 名成年创伤患者进行前瞻性招募，前瞻性采集血液样本。通过比较 4 种方法（ROTEM® Delta 和 Sigma FIBTEM A5、TEG® 6s CFF MA 和金标准 Clauss 纤维蛋白原）测量的功能性纤维蛋白原水平，计算一致性。
在 ROTEM® Delta 和新一代 ROTEM® Sigma 机器之间进行比较时，通过计算组内相关系数（ICC），FIBTEM A5 的一致性在所有分析时间点均≥0.73，平均差值（Sigma 减去 Delta）为 0.10-3.57mm。在 ROTEM® Sigma FIBTEM A5 和 TEG® 6s CFF MA 之间进行比较时，ICC 值为 0.55-0.82 和 ICC 值为 4.69-7.97（CFF MA 减去 A5）。在 ROTEM® Sigma FIBTEM A5 和 Clauss 纤维蛋白原分析（CFA）之间进行比较时，在具有统计学意义的简单线性回归模型中，R 值为 0.25-0.67，在 TEG® 6s CFF MA 和 CFA（CFA）之间进行比较时，R 值为 0.65-0.82，尽管后一种比较并非所有差异均具有统计学意义。综合所有时间点的关系，Clauss 纤维蛋白原（CF）（g/L）=0.21x+0.004（其中 x=ROTEM® Sigma FIBTEM A5，单位为 mm）和（g/L）=0.16x-0.06（其中 x=TEG® 6s CFF MA，单位为 mm）。
本研究显示，四种不同的功能性纤维蛋白原检测方法之间具有可接受的一致性，当前代和前代 ROTEM® 机器（Sigma、Delta）通过 FIBTEM 检测法测量功能性纤维蛋白原时性能相似。这表明，为 ROTEM® Delta 设计的止血复苏算法可应用于 ROTEM® Sigma，以指导纤维蛋白原替代。
