Department of Anaesthesia, Sir Charles Gairdner Hospital, Australia.
Department of Anaesthesia, St John of God Hospital, Australia.
Anaesth Intensive Care. 2022 Sep;50(5):388-395. doi: 10.1177/0310057X211067807. Epub 2022 Jun 19.
The ROTEM®delta (TEM Innovations GmbH, Munich, Germany) has been used extensively worldwide for the assessment of coagulation in cardiac surgical patients. Recently, a new cartridge-based ROTEM device (ROTEM®sigma, TEM Innovations GmbH, Munich, Germany) has become available. In this paper we report an audit of the diagnostic accuracy of the ROTEM sigma for the identification of hypofibrinogenaemia in cardiac surgical patients. We hypothesised that the diagnostic accuracy of the ROTEMsigma for the identification of hypofibrinogenaemia would be in a similar range to that previously reported for the ROTEMdelta. Simultaneous blood samples for Clauss laboratory fibrinogen and ROTEMsigma FIBTEM measurements were obtained immediately after heparin reversal post-cardiopulmonary bypass in 200 adult cardiac surgical patients. The sensitivity, specificity, and positive and negative predictive values for FIBTEM A5 and A10 for the identification of hypofibrinogenaemia (Clauss fibrinogen <1.5 g/l) were calculated. The prevalence of hypofibrinogenaemia across the 200 patients was 8%. The mean sensitivity and specificity of FIBTEM A10 ≤8 mm for the identification of hypofibrinogenaemia were 0.75 and 0.90 respectively, which are in a similar range to that reported in several previous studies using the ROTEMdelta. For FIBTEM A5 ≤6 mm the values were 0.63 and 0.98 respectively. The predictive values were also in a similar range to those previously reported for the ROTEMdelta, with low false negative rates (2% for A10 ≤8 mm; 3% for A5 ≤6 mm). These findings support the use of the ROTEMsigma as an alternative to the ROTEMdelta for the identification of hypofibrinogenaemia post-cardiopulmonary bypass in cardiac surgical patients. However, further studies are required in other settings.
ROTEM® delta（TEM 创新有限公司，慕尼黑，德国）已在全球范围内广泛用于评估心脏外科患者的凝血情况。最近，一种新的基于试剂盒的 ROTEM 设备（ROTEM®sigma，TEM 创新有限公司，慕尼黑，德国）已投入使用。本文报告了一项关于 ROTEM sigma 诊断心脏外科患者低纤维蛋白原血症的准确性的审计。我们假设 ROTEM sigma 识别低纤维蛋白原血症的诊断准确性与之前报道的 ROTEM delta 相似。在 200 例成年心脏外科患者体外循环后肝素逆转后，立即同时采集 Clauss 实验室纤维蛋白原和 ROTEM sigma FIBTEM 测量的血液样本。计算 FIBTEM A5 和 A10 识别低纤维蛋白原血症（Clauss 纤维蛋白原<1.5g/l）的敏感性、特异性、阳性和阴性预测值。200 例患者中低纤维蛋白原血症的患病率为 8%。FIBTEM A10≤8mm 识别低纤维蛋白原血症的平均敏感性和特异性分别为 0.75 和 0.90，与之前使用 ROTEM delta 的几项研究报道的范围相似。对于 FIBTEM A5≤6mm，值分别为 0.63 和 0.98。预测值也与之前报道的 ROTEM delta 相似，假阴性率较低（A10≤8mm 为 2%；A5≤6mm 为 3%）。这些发现支持 ROTEM sigma 作为 ROTEM delta 的替代方法，用于识别心脏外科患者体外循环后低纤维蛋白原血症。然而，还需要在其他环境中进行进一步的研究。
