A multicenter, prospective evaluation of the Chinese Society of Thrombosis and Hemostasis Scoring System for disseminated intravascular coagulation

Highlights

• The diagnostic rates for DIC from the three scoring systems varied with different illnesses.

• The rates of concordance in the diagnosis of DIC between the CDSS and other two scoring systems were close to 80%.

• When the ISTH, JMHW and prognosis was used as the gold standard, the AUC for CDSS had a slight advantage over the two others.

• The CDSS DIC was an independent predictor of mortality, and the CDSS score may reflect DIC severity.

Abstract

Introduction

Disseminated intravascular coagulation (DIC) is a severe complication of critical conditions. There are several scoring systems used for the diagnosis of DIC, including the International Society on Thrombosis and Hemostasis (ISTH) Overt-DIC criteria, the Japanese Ministry of Health and Welfare (JMHW) criteria and the Chinese Society of Thrombosis and Hemostasis scoring system for DIC (CDSS). The objective of this prospective study was to evaluate the accuracy and predictive value of the CDSS.

Materials and methods

1318 patients, aged 18–70 years old and suspected of DIC were enrolled from 18 hospitals across China. Participants were divided into two groups for analysis (group 1, non-hematological diseases; group 2, hematological diseases). 242 patients were excluded because of incomplete data collection and failure to follow-up.

Results and conclusions

The rates of concordance of diagnosis of DIC between the CDSS and two other scoring systems were close to 80%. The area under ROC curves of CDSS had a slight advantage when using the ISTH, JMHW criteria or prognosis as gold standard, respectively. The CDSS DIC was an independent predictor of mortality, and its odds-ratio was superior or comparable to that of the ISTH and JMHW criteria in the two groups. The CDSS DIC score also had a significant correlation with the APACHE II and SOFA score (p < 0.05). In summary, as a quantification standard of the Chinese experts' consensus, the CDSS is conducive to the standardized diagnosis of DIC because of its favorable diagnostic and prognostic utility.

Introduction

Disseminated intravascular coagulation (DIC) is a common and severe complication of critical conditions and is highly life-threatening. It presents with a broad spectrum of clinical signs, ranging from prothrombotic state to bleeding or both [1]. As an acquired syndrome resulting from a wide array of underlying diseases, DIC is characterized by systemic intravascular activation of coagulation, induced by and, in turn, deteriorating micro-vascular damage. At its worse, DIC can cause organ dysfunction and multiple hemorrhages [[2], [3], [4], [5]]. Timely intervention and early treatment can significantly improve the outcome of DIC patients [6,7]. Hence, prompt recognition and diagnosis of DIC are essential. However, there is no unique clinical manifestation or laboratory test which can verify or deny a diagnosis of DIC with appropriate sensitivity and specificity [8].

Over the past decades, several DIC diagnostic scoring systems have been developed based on a combination of clinical and laboratory findings. Currently, the three primary diagnostic criteria for DIC are the Japanese Ministry Health and Welfare (JMHW) criteria [9], the International Society on Thrombosis and Homeostasis (ISTH) Overt-DIC criteria [2] and the Japanese Association for Acute Medicine (JAAM) criteria [10]. Many retrospective or prospective studies [[9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20]], have shown that these criteria are useful for DIC diagnosis, although it is still controversial whether they are optimal in terms of diagnostic and prognostic performance. Wada et al. concluded that the JMHW criteria had poor sensitivity for discerning infection-induced DIC [21]. The ISTH overt-DIC criteria had low sensitivity and high specificity for DIC diagnosed against the JMHW criteria, which could be further improved by adjusting the cut-off values of coagulation tests [11]. Even though it is more sensitive than the JMHW and the ISTH criteria in critically-ill patients, the JAAM criteria showed poor specificity and cannot be applied to all underlying diseases [10]. Thus, it might be confusing for clinicians to choose one optimal diagnostic system for the clinical diagnosis of DIC. Furthermore, the JAAM criteria have been modified by several teams from different perspectives. Toshiaki et al. replaced the systemic inflammatory response syndrome score with antithrombin activity in the JAAM criteria to discriminate DIC in patients with sepsis [22]. Yutaka et al. integrated two endothelial molecular markers into the JAAM criteria, to improve its predictive value in sepsis patients [23]. Besides, the Japanese Society on Thrombosis and Hemostasis proposed the addition of one newly modified diagnostic criteria for DIC based on the underlying pathology [21]. However, the molecule markers adopted in these latter three criteria are not available in most Chinese hospitals. Therefore, these standards have not been universally adopted to diagnose DIC in China.

As early as 1986, the first consensus of Chinese experts on DIC diagnosis was proposed and has been updated several times since [24]. These consensuses consist of qualitative but not quantitative rules, for combining clinical and laboratory findings. However, clinicians often interpret DIC symptoms differently, which makes clinical management quite challenging. Consequently, the rates of both missed diagnosis and misdiagnosis of DIC are high [25], leading to high mortality and medical cost. In 2014, the Chinese Society of Thrombosis and Hemostasis scoring system for DIC (CDSS) was proposed to ameliorate the status quo based on a combination of underlying diseases, clinical manifestations and several available routine coagulation tests [26]. One feature of the CDSS is that, it calculates DIC score separately in cases of hematological diseases. Based on the Chinese experts' consensus and retrospective data, a score of ≥6 is compatible with the diagnosis of DIC in patients with hematological diseases, and ≥ 7 in patients with other causes, respectively [26]. The retrospective study divided the subjects into two groups and then analyzed them independently (group 1: patients without hematological diseases; group 2: those with hematological diseases). That study showed that the CDSS had good diagnostic and prognostic value [26]. However, the study was a single-center retrospective study and further evaluations in multicenter, prospective studies were needed. In 2016, our core center led an eighteen-center prospective study, in which 1076 patients were finally admitted for analysis (753 in group 1 and 323 in group 2). The patients in group 1 were divided into infection group with infection and non-infection group with other underlying diseases [27]. Our study demonstrated that the CDSS has a potential to be developed as an excellent diagnostic and prognostic tool for DIC for both infectious and non-infectious patients [27]. However, the previous study did not enroll patients with hematological diseases. The present study compares the CDSS with two other diagnostic systems from a comprehensive perspective in a larger population with a broader range of pathologies and, demonstrates the potential utility and applicability of the CDSS.