protocolSection identificationModule nctId: NCT06373159, orgStudyIdInfo id: 22643, briefTitle: An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.In this study, researchers will assess patient data from a hospital database in Japan.The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.To learn about this, researchers will collect the following information:* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis* The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)* The number of days between diagnosis of sepsis and the beginning of DICResearchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.In this study, only available data from routine care are collected., conditionsModule conditions: Sepsis, conditions: Disseminated Intravascular Coagulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5740, type: ESTIMATED, armsInterventionsModule interventions name: No study intervention, outcomesModule primaryOutcomes measure: Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up, primaryOutcomes measure: Distribution of JAAM DIC score, primaryOutcomes measure: Distribution of ISTH DIC score, primaryOutcomes measure: Distribution of MHLW DIC score, primaryOutcomes measure: Distribution of SOFA score, primaryOutcomes measure: Days from sepsis diagnosis to the onset of DIC, secondaryOutcomes measure: Number of participants per clinical characteristics, secondaryOutcomes measure: Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC, secondaryOutcomes measure: Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC, secondaryOutcomes measure: Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC, secondaryOutcomes measure: Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC, secondaryOutcomes measure: Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC, secondaryOutcomes measure: Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC, secondaryOutcomes measure: Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC, secondaryOutcomes measure: Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC, secondaryOutcomes measure: Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, city: Tokyo, zip: 100-8265, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False