Abstract
Objective: Accurate and early diagnosis are important in the management of disseminated intravascular coagulation (DIC). New specific coagulation markers have always been explored. In this study, we employed new automation technology to detect plasma biomarkers, including Thrombin-Antithrombin Complex (TAT), α2-Plasmininhibitor-Plasmin Complex(PIC), thrombomoduline (TM), tissue plasminogen activator-inhibitor Complex (tPAIC), and evaluated their diagnostic performance for DIC in Chinese population.
Method: A prospective observational study was conducted in 9 hospitals located across the entire China. 406 patients suspected DIC and 137 normal people were included. These four molecular markers were measured by qualitative chemiluminescence enzyme immunoassay performed on automated analyzers HISCL. All patients suspected DIC were followed for development of overt-DIC in 7 days, and for mortality in 28 days.
Results: The plasm level of TAT, PIC, tPAIC and TM in normal Chinese people were 1.1 (0.7-1.6), 0.44 (0.37-0.56), 7.2(5.1-9.3) and 8.6 (7.3-9.9). According to the ISTH scoring system, 146 patients were diagnosed as overt-DIC, and 37 were diagnosed as pre-DIC. All four biomarkers were significantly higher in DIC group than non-overt DIC group, and tPAIC and TM were significantly higher in pre-DIC group than non-overt DIC group (Table 1). Besides, these molecular markers were different among various underlying diseases(Fig.1). As shown in the ROC assay, the efficiency of TAT, PIC, tPAIC and TM discriminated well between overt- DIC with pre-DIC and non-overt DIC (AUROC, 0.64 (95% CI, 0.58 to 0.69); 0.63 (0.57 to 0.68); 0.63 (0.58 to 0.69);0.73 (0.68 to 0.78), respectively)(Table 2). In the combination assay, the AUROC rose up to 0.955 (0.94 to 0.97) when in addition with global coagulation tests (Fig.2). Moreover, the ISTH DIC scores showed significant correlation with these molecular markers' levels. The mortality of DIC, pre-DIC and non-DIC was 33.56%, 51.35% and 8.97%, respectively. Among the significant diagnostic markers for DIC, TAT, tPAIC and TM were also good predictors of 28-day mortality (AUROC, 0.65, 0,76 and 0.76, respectively), high levels of them were associated with poor outcome(Fig.3).
Conclusion: These four biomarkers have good diagnostic performance and prognostic value in DIC patients with different underlying diseases. They can also be applied in classification and stages of DIC. Moreover, combination of four makers demonstrate better behavior than single one.
No relevant conflicts of interest to declare.
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