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Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation.

ABSTRACT: Since July 2022, obstetrical disseminated intravascular coagulation (DIC) in Japan has been diagnosed based on the new criteria (tentative version), which assesses the main underlying disease, fibrinogen level, and fibrin/fibrinogen degradation products or D-dimer level. In June 2024, the tentative version underwent minor revision and the final version was released. The previous Japanese criteria assessed underlying disease, clinical symptoms, and various laboratory findings. This study aimed to prove the effectiveness, reliability, and validity of the new criteria (final version). We analyzed 212 women with singleton pregnancies who delivered after 22 gestational weeks and experienced blood loss ≥ 1000 mL during vaginal delivery or ≥ 2000 mL during cesarean section. Those with missing laboratory findings before receiving blood transfusion at delivery were excluded. In the obstetrical DIC group, the frequency of fibrinogen levels < 150 mg/dL was significantly higher than in the control group (90% vs. 5%, p < 0.0001), as was the frequency of scores ≥ 8 according to the previous Japanese criteria (100% vs. 10%, p < 0.0001). Cronbach alpha was 0.757 and Spearman's rank-order correlation was 0.558 between the new and previous criteria. In conclusion, we proved the effectiveness, reliability, and validity of the Japanese new criteria (final version) to diagnose obstetrical DIC.

SUBMITTER: Morikawa M

PROVIDER: S-EPMC11291721 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation.

Morikawa Mamoru M Takeda Yoshiharu Y Matsunaga Shigetaka S Makino Shintaro S Eto Eriko E Serizawa Mariko M Nii Masafumi M Takeda Jun J Masuyama Hisashi H Itakura Atsuo A

Scientific reports 20240730 1

Since July 2022, obstetrical disseminated intravascular coagulation (DIC) in Japan has been diagnosed based on the new criteria (tentative version), which assesses the main underlying disease, fibrinogen level, and fibrin/fibrinogen degradation products or D-dimer level. In June 2024, the tentative version underwent minor revision and the final version was released. The previous Japanese criteria assessed underlying disease, clinical symptoms, and various laboratory findings. This study aimed to ...[more]

PMID: 39085285

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Project description:IntroductionSince disseminated intravascular coagulation (DIC) was first described, it has been considered a serious disease of the coagulation system and a major challenge to clinicians. Currently, several important knowledge gaps remain. The DANish Disseminated Intravascular Coagulation (DANDIC) Cohort Study will aim to answer questions regarding the incidence and mortality of patients with DIC including time trends. The study will also identify prognostic factors that may guide personalised prevention and treatment. Furthermore, the study will describe treatment patterns and the safety and effectiveness of various treatment modalities.Methods and analysisWe will establish the DANDIC Cohort using data collected in daily clinical practice from the Central Denmark Region, which covers approximately 1.3 million residents. The study period will encompass 1 January 2011 through 1 July 2021. Potential DIC cases will be identified from the hospital laboratory database, based on coagulation biomarkers, and diagnoses will be adjudicated by medical experts. The dataset will be enriched with detailed clinical data from electronic medical charts on aetiologies, bleeding, microthrombus formation, organ failure, thrombosis, treatments and comorbidities. The dataset will also take advantage of in-hospital data with longitudinal information on laboratory records, transfusions, microbiology and treatments. It will be possible to merge this dataset with other unique Danish health registries with more than 10 years of virtually complete follow-up. The project will use state-of-the-art epidemiological and biostatistical methods.Ethics and disseminationThe project has been approved by the Danish Patient Safety Authority (31-1521-452), the Central Denmark Region (1-45-70-83-21), the Danish Data Protection Agency (1-16-02-258-21) and all the hospital chairs. Register-based studies require no ethical approval in Denmark. The results will be disseminated in international peer-reviewed journals.

Project description:ObjectiveEven though patients with sepsis and DIC have a higher mortality rate compared to those without DIC, screening for DIC is not currently part of sepsis management protocols. This may be due to a lack of literature on the frequency of DIC occurrence in sepsis patients, as well as the absence of evidence on the optimal DIC criteria to use for identifying DIC and predicting mortality among the five criteria available. To address this gap, this study investigates the predictive value of five different criteria for diagnosing DIC and its relationship to patient outcomes in our population of sepsis patients.MethodsIn the Medicine department of Aga Khan University Hospital, a retrospective observational study was conducted, enrolling all adult patients with International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) coding of sepsis and clinical suspicion of DIC between January 2018 and December 2020. To diagnose DIC, five different criteria were utilized, namely the International Society of Thrombosis and Hemostasis (ISTH), the Korean Society on Thrombosis and Hemostasis (KSTH), the Japanese Association for Acute Medicine (JAAM), the revised-JAAM (RJAAM), and the Japanese Ministry of Health and Welfare (JMHW). The study analyzed the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of these five criteria, as well as the overall prediction of mortality.ResultsOf 222 septic patients included in this study with clinical suspicion of DIC, 94.6% of patient had DIC according to KSTH criteria, followed by JAAM (69.4%), ISTH (64.0%), JMHW (53.2%) and lastly R-JAAM (48.6%). KSTH had sensitivity of 95.4% in diagnosing DIC and predicting mortality with a positive predictive value of 70% but specificity of 7.3% only. JAAM had sensitivity of 75.9%, positive predictive value of 75.9% with a specificity of 45.5%. ISTH had sensitivity of 69.4%, positive predictive value 75.3% and specificity of 48.5%.ConclusionDIC can impose a significant burden on septic patients and its presence can lead to higher mortality rates. Early detection through screening for DIC in septic patients can potentially reduce mortality. However, it is necessary to identify the most appropriate diagnostic criteria for each population, as various criteria have demonstrated different performance in different populations. Establishing a gold standard for each population can aid in accurate diagnosis of DIC.

Project description:BackgroundThe development of disseminated intravascular coagulation (DIC) in patients with sepsis has been repeatedly confirmed as a factor associated with poor prognosis. Anticoagulant therapy has been expected to improve sepsis patient outcomes, whereas no randomized controlled trials have demonstrated the survival benefit of anticoagulant therapies in non-specific overall sepsis. Patient selection based on the component of "high disease severity" in addition to "sepsis with DIC" has recently proved important in identifying appropriate targets for anticoagulant therapy. The aims of this study were to characterize "severe" sepsis DIC patients and to identify the patient population benefiting from anticoagulant therapy.MethodsThis retrospective sub-analysis of a prospective multicenter study included 1,178 adult patients with severe sepsis from 59 intensive care units in Japan from January 2016 to March 2017. We examined the association of patient outcomes, including organ dysfunction and in-hospital mortality, with the DIC score and prothrombin time-international normalized ratio (PT-INR), one of the components of the DIC score, using multivariable regression models including the cross-product term between these indicators. Multivariate Cox proportional hazard regression analysis with non-linear restricted cubic spline including a three-way interaction term (anticoagulant therapy × the DIC score × PT-INR) was also performed. Anticoagulant therapy was defined as the administration of antithrombin, recombinant human thrombomodulin, or their combination.ResultsIn total, we analyzed 1013 patients. The regression model showed that organ dysfunction and in-hospital mortality deteriorated with higher PT-INR values in the range of < 1.5 and that this trend was more pronounced with higher DIC scores. Three-way interaction analysis demonstrated that anticoagulant therapy was associated with better survival outcome in patients with a high DIC score and high PT-INR. Furthermore, we identified a DIC score ≥ 5 and PT-INR ≥ 1.5 as the clinical threshold for identification of optimal targets for anticoagulant therapy.ConclusionsThe combined use of the DIC score and PT-INR helps in selecting the optimal patient population for anticoagulant therapy in sepsis-induced DIC. The results obtained from this study will provide valuable information regarding the study design of randomized controlled trials examining the effects of anticoagulant therapy for sepsis.Trial registrationUMIN-CTR, UMIN000019742. Registered on November 16, 2015.

Project description:Backgroundsepsis is a life-threatening organ dysfunction caused by an excessive host immunological response to infection. The incidence of sepsis is increasing every year, and sepsis is the primary cause of mortality in intensive care units (ICUs). DIC is a coagulopathy syndrome that causes microvascular and macrovascular thrombosis and increases the risk of bleeding due to consumptive coagulopathy. The pathophysiology of DIC in sepsis is complex, and further research is required to investigate the involved mechanisms and risk factors.Methodthis study is a prognostic analysis of a retrospective cohort. Samples were patients diagnosed with sepsis and admitted to Cipto Mangunkusumo National General Hospital from January 2016 to October 2022. Research subjects were followed until occurrence of DIC during sepsis or recovery from sepsis. The research subjects were selected from medical records using a consecutive total sampling approach. The inclusion criteria were patients aged ≥18 years old and diagnosed with sepsis according to qSOFA criteria with a score of 2. The exclusion criterion was an incomplete medical record. Bivariate and multivariate logistic regression analyses were performed to determine which independent variables contributed to the incidence of DIC and obtain the odds ratios (ORs). p < 0.05 was considered to indicate a statistically significant difference.Resultsa total of 248 patients were included after considering the inclusion and exclusion criteria. Of these, 50 (20.2%) septic patients developed DIC. In the multivariate analysis, albumin ≤2.5 g/dL (OR: 2.363; 95% CI: 1.201-4.649), respiratory infection (OR: 2.414; 95% CI: 1.046-5.571), and antibiotic treatment ≥1 h (OR: 2.181; 95% CI: 1.014-4.689) were associated with DIC development. On the basis of the ROC curve, the area under the curve (AUC) was determined to be 0.705 with 95% CI = (0.631-0.778).Conclusionin our study, the prevalence of DIC in septic patients was 20.2%. Low albumin, respiratory infection, and antibiotic treatment ≥1 h were found to be risk factors for development of DIC in septic patients.

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Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation.

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Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation.

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