The Transition of the Criteria for Disseminated Intravascular Coagulation and the Targeted Patients in Randomized Controlled Trials over the Decades: a Scoping Review

Overview

Journal Thromb J

Publisher Biomed Central

Date 2024 Dec 23

PMID 39716150

Authors

Tadashi Matsuoka

Kazuma Yamakawa

Yutaka Umemura

Koichiro Homma

Toshiaki Iba

Junichi Sasaki

Affiliations

Soon will be listed here.

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.

References

Eisele B, Lamy M, Thijs L, Keinecke H, Schuster H, Matthias F . Antithrombin III in patients with severe sepsis. A randomized, placebo-controlled, double-blind multicenter trial plus a meta-analysis on all randomized, placebo-controlled, double-blind trials with antithrombin III in severe sepsis. Intensive Care Med. 1998; 24(7):663-72. DOI: 10.1007/s001340050642. View

Abraham E, Reinhart K, Svoboda P, Seibert A, Olthoff D, Dal Nogare A . Assessment of the safety of recombinant tissue factor pathway inhibitor in patients with severe sepsis: a multicenter, randomized, placebo-controlled, single-blind, dose escalation study. Crit Care Med. 2001; 29(11):2081-9. DOI: 10.1097/00003246-200111000-00007. View

Umemura Y, Okada N, Ogura H, Oda J, Fujimi S . A machine learning model for early and accurate prediction of overt disseminated intravascular coagulation before its progression to an overt stage. Res Pract Thromb Haemost. 2024; 8(5):102519. PMC: 11363840. DOI: 10.1016/j.rpth.2024.102519. View

Gando S, Wada H, Asakura H, Iba T, Eguchi Y, Okamoto K . Evaluation of new Japanese diagnostic criteria for disseminated intravascular coagulation in critically ill patients. Clin Appl Thromb Hemost. 2005; 11(1):71-6. DOI: 10.1177/107602960501100108. View

Osawa I, Goto T, Kudo D, Hayakawa M, Yamakawa K, Kushimoto S . Targeted therapy using polymyxin B hemadsorption in patients with sepsis: a post-hoc analysis of the JSEPTIC-DIC study and the EUPHRATES trial. Crit Care. 2023; 27(1):245. PMC: 10286480. DOI: 10.1186/s13054-023-04533-3. View

Baudo F, Caimi T, de Cataldo F, Ravizza A, Arlati S, Casella G . Antithrombin III (ATIII) replacement therapy in patients with sepsis and/or postsurgical complications: a controlled double-blind, randomized, multicenter study. Intensive Care Med. 1998; 24(4):336-42. DOI: 10.1007/s001340050576. View

Hsu J, Chen H, Chiu D, Chen J, Huang C, Hwang T . Efficacy of gabexate mesilate on disseminated intravascular coagulation as a complication of infection developing after abdominal surgery. J Formos Med Assoc. 2004; 103(9):678-84. View

Mori S, Ai T, Sera T, Ochiai K, Otomo Y . Human Soluble Recombinant Thrombomodulin, ART-123, Resolved Early Phase Coagulopathies, but Did Not Significantly Alter the 28 Day Outcome in the Treatment of DIC Associated with Infectious Systemic Inflammatory Response Syndromes. J Clin Med. 2019; 8(10). PMC: 6832475. DOI: 10.3390/jcm8101553. View

Yamakawa K, Umemura Y, Murao S, Hayakawa M, Fujimi S . Optimal Timing and Early Intervention With Anticoagulant Therapy for Sepsis-Induced Disseminated Intravascular Coagulation. Clin Appl Thromb Hemost. 2019; 25:1076029619835055. PMC: 6714922. DOI: 10.1177/1076029619835055. View

10.

Ogura H, Gando S, Saitoh D, Takeyama N, Kushimoto S, Fujishima S . Epidemiology of severe sepsis in Japanese intensive care units: a prospective multicenter study. J Infect Chemother. 2014; 20(3):157-62. DOI: 10.1016/j.jiac.2013.07.006. View

11.

Gando S, Iba T, Eguchi Y, Ohtomo Y, Okamoto K, Koseki K . A multicenter, prospective validation of disseminated intravascular coagulation diagnostic criteria for critically ill patients: comparing current criteria. Crit Care Med. 2006; 34(3):625-31. DOI: 10.1097/01.ccm.0000202209.42491.38. View

12.

Nishiyama T, Matsukawa T, Hanaoka K . Is protease inhibitor a choice for the treatment of pre- or mild disseminated intravascular coagulation?. Crit Care Med. 2000; 28(5):1419-22. DOI: 10.1097/00003246-200005000-00027. View

13.

Kienast J, Juers M, Wiedermann C, Hoffmann J, Ostermann H, Strauss R . Treatment effects of high-dose antithrombin without concomitant heparin in patients with severe sepsis with or without disseminated intravascular coagulation. J Thromb Haemost. 2006; 4(1):90-7. DOI: 10.1111/j.1538-7836.2005.01697.x. View

14.

Iba T, Di Nisio M, Levy J, Kitamura N, Thachil J . New criteria for sepsis-induced coagulopathy (SIC) following the revised sepsis definition: a retrospective analysis of a nationwide survey. BMJ Open. 2017; 7(9):e017046. PMC: 5623518. DOI: 10.1136/bmjopen-2017-017046. View

15.

Gando S . Role of fibrinolysis in sepsis. Semin Thromb Hemost. 2013; 39(4):392-9. DOI: 10.1055/s-0033-1334140. View

16.

Taylor Jr F, Toh C, Hoots W, Wada H, Levi M . Towards definition, clinical and laboratory criteria, and a scoring system for disseminated intravascular coagulation. Thromb Haemost. 2002; 86(5):1327-30. View

17.

Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, Rodriguez A . Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA. 2003; 290(2):238-47. DOI: 10.1001/jama.290.2.238. View

18.

Kobayashi N, Maekawa T, Takada M, Tanaka H, Gonmori H . Criteria for diagnosis of DIC based on the analysis of clinical and laboratory findings in 345 DIC patients collected by the Research Committee on DIC in Japan. Bibl Haematol. 1983; (49):265-75. DOI: 10.1159/000408467. View

19.

Yamakawa K, Umemura Y, Hayakawa M, Kudo D, Sanui M, Takahashi H . Benefit profile of anticoagulant therapy in sepsis: a nationwide multicentre registry in Japan. Crit Care. 2016; 20(1):229. PMC: 4966726. DOI: 10.1186/s13054-016-1415-1. View

20.

Iba T, Umemura Y, Watanabe E, Wada T, Hayashida K, Kushimoto S . Diagnosis of sepsis-induced disseminated intravascular coagulation and coagulopathy. Acute Med Surg. 2019; 6(3):223-232. PMC: 6603393. DOI: 10.1002/ams2.411. View