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. 2024 Dec 23;22(1):112.
doi: 10.1186/s12959-024-00681-w.

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

Tadashi Matsuoka  1 , Kazuma Yamakawa  2 , Yutaka Umemura  3 , Koichiro Homma  4 , Toshiaki Iba  5 , Junichi Sasaki  4
Affiliations

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

Tadashi Matsuoka et al. Thromb J. .

Abstract

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.

Keywords: Anticoagulant therapy; Diagnostic criteria.; Disseminated intravascular coagulation; Sepsis.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable (scoping review of published literature). Consent for publication: Not applicable. Competing interests: TM has received research grants from Japan Blood Products Organization. KY has received research grants from Asahi Kasei Pharma and Japan Blood Products Organization. T.I has received a research grant from JIMRO and has participated in advisory boards of Japan Blood Products Organization and Toray Medical.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram. PRISMA preferred reporting items for systematic reviews and meta-analyses DIC: disseminated intravascular coagulation, RCT: randomized control trial
Fig. 2
Fig. 2
Transition of DIC criteria used in RCTs and post-hoc/subgroup analyses 1st upper box describes the criteria used in the study. 2nd upper box is the treatment drug in the study. 2nd lower box is the country where the study was conducted. 1st lower box is the severity scale for inclusion in the study
See this image and copyright information in PMC

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