The transition of the criteria for disseminated intravascular coagulation and the targeted patients in randomized controlled trials over the decades: a scoping review

Background: Disseminated intravascular coagulation (DIC) is a severe complication in septic patients. The Japanese Ministry of Health and Welfare (JMHW)-DIC criteria, the first DIC criteria, were established in 1983, and several other criteria have been proposed since then, including the International Society on Thrombosis and Haemostasis (ISTH)-overt DIC criteria and the Japanese Association for Acute Medicine (JAAM) DIC criteria. This study aimed to look into the transition of DIC criteria used in randomized controlled trials (RCTs) for sepsis-induced DIC.

Methods: We searched PubMed, Scopus, and the Cochrane Central Register of Controlled Trials for English-language studies published through September 30, 2023. Two reviewers looked through citations that assessed the DIC criteria used in RCTs and their secondary analyses. Data on DIC diagnostic criteria, patient characteristics, interventions, and results were gathered.

Results: Twenty-one studies (thirteen RCTs: JMHW-DIC in 5, JAAM-DIC in 4, the sepsis-induced coagulopathy (SIC) in 2; and eight secondary analyses: ISTH-overt DIC in 3, single parameter in 5) were eligible for inclusion. Most RCTs were conducted in Japan, using the criteria of JMHW-DIC, which were followed by JAAM-DIC. Recently, SIC has been used in international RCTs. Meanwhile, other countries tended to conduct RCTs that focused on sepsis, with secondary analyses for DIC using the ISTH-overt DIC criteria.

Conclusions: The criteria used in RCTs have changed over decades, from the JMHW-DIC to the JAAM-DIC criteria, and the ISTH-overt DIC criteria were retained in the secondary analysis. Based on these findings, additional research is needed to determine the best criterion for diagnosing septic patients.