Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-03-05 @ 10:59 AM
Study NCT ID:
NCT06373159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D004211', 'term': 'Disseminated Intravascular Coagulation'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5740}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}, {'measure': 'Distribution of JAAM DIC score', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'The Japanese Association for Acute Medicine (JAAM) DIC scoring algorithm includes a number of variables but in addition specific criteria for evidence of a Systemic Inflammatory Response Syndrome (SIRS). JAAM DIC score \\>= 4 supports a diagnosis of DIC. DIC: disseminated intravascular coagulation'}, {'measure': 'Distribution of ISTH DIC score', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'The International Society on Thrombosis Haemostasis (ISTH) DIC score is a simple scoring system produced by the ISTH group for the diagnosis of DIC depending on the Platelet count, the PT, the fibrinogen level and critically the FDP/D-Dimer results. A total score of ≥5 = DIC as long as the score is associated with a clinical disorder known to cause DIC. DIC: disseminated intravascular coagulation'}, {'measure': 'Distribution of MHLW DIC score', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'The Japanese Ministry of Health, Labor and Welfare (MHLW) DIC score is a scoring system for the diagnosis of overt DIC. MHLW DIC score ≥7 is defined as DIC. DIC: disseminated intravascular coagulation'}, {'measure': 'Distribution of SOFA score', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'The Sequential Organ Failure Assessment (SOFA) score is a scoring system based on performance of respiratory, coagulation, liver, cardiovascular, central nervous system, and kidney. The higher the SOFA score, the higher the likely mortality. DIC: disseminated intravascular coagulation'}, {'measure': 'Days from sepsis diagnosis to the onset of DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}], 'secondaryOutcomes': [{'measure': 'Number of participants per clinical characteristics', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'Clinical characteristics (e.g., demographics, comorbidities, medical history) in patients with sepsis, thrombocytopenic sepsis and septic shock, respectively; in patients with sepsis in different definitions (diagnosis codes, laboratory values, and procedure codes); at the onset of DIC in patients who developed sepsis-associated DIC. DIC: disseminated intravascular coagulation'}, {'measure': 'Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}, {'measure': 'Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'Clinical outcomes are assessed at 14 days, 28 days, 60 days, 183 days, 365 days (1 year) and 730 days (2 years) of follow up. Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization. DIC: disseminated intravascular coagulation'}, {'measure': 'Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'Clinical outcomes are assessed at 14 days, 28 days, 60 days, 183 days, 365 days (1 year) and 730 days (2 years) of follow up. Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization. DIC: disseminated intravascular coagulation'}, {'measure': 'Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}, {'measure': 'Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}, {'measure': 'Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.'}, {'measure': 'Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}, {'measure': 'Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'DIC: disseminated intravascular coagulation'}, {'measure': 'Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC', 'timeFrame': 'Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023', 'description': 'Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombocytopenic sepsis', 'Septic shock'], 'conditions': ['Sepsis', 'Disseminated Intravascular Coagulation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': "Click here for access to information about Bayer's transparency standards and Bayer studies."}]}, '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.\n\nIn observational studies, only observations are made without participants receiving any advice or changes to their healthcare.\n\nDIC 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.\n\nTo 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.\n\nIn this study, researchers will assess patient data from a hospital database in Japan.\n\nThe 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.\n\nTo learn about this, researchers will collect the following information:\n\n* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis\n* 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)\n* The number of days between diagnosis of sepsis and the beginning of DIC\n\nResearchers 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.\n\nIn this study, only available data from routine care are collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Source population are patients in hospitals providing electronic medical record (EMR) and diagnosis procedure combination (DPC) data to TXP Medical in Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sepsis patient cohort\n\n * Sepsis patients\n * Age ≥18 years\n * Subgroups:\n\n * Sepsis with thrombocytopenia patient cohort\n * Septic shock patient cohort\n* Sepsis-associated DIC patient cohort\n\n * DIC patients in sepsis patient cohort\n * Subgroups:\n\n * Organ failure: kidney (Serum creatinine (SCr) \\< 1.2 mg/dl and ≥ 1.2 mg/dl)\n * Organ failure: liver (bilirubin \\< 1.2 mg/dl and ≥ 1.2 mg/dl)\n * Organ failure: cardiovascular (with and without catecholamine or vasopressin)\n * With low molecular weight (LMW) heparins, unfractionated heparins, and both\n * With and without DIC treatment\n\n * Priority 1\\_Anticoagulants specifically used in Japan (recombinant antithrombin, recombinant thrombomodulin, human anti-thrombin III)\n * Priority 1 + Priority 2\\_Drugs for sepsis-associated DIC (LMW heparins, unfractionated heparins, protease inhibitors)\n * Priority 1 + Priority 2 + Priority 3\\_antibiotics (antifungals), and/or steroids\n* Non-sepsis-associated DIC patient cohort\n\n * Hematopoietic malignant tumor patients\n * DIC patients\n * Age ≥18 years\n\nExclusion Criteria:\n\n* Sepsis patient cohort: None\n* Sepsis-associated DIC patient cohort: None\n* Non-sepsis-associated DIC patient cohort: Sepsis patients'}, 'identificationModule': {'nctId': 'NCT06373159', 'briefTitle': 'An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Study for the Disseminated Intravascular Coagulation Among Patients With Sepsis in Japan: A Hospital-based Cohort Study', 'orgStudyIdInfo': {'id': '22643'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis patient cohort', 'description': 'Patients diagnosed with sepsis in patient inclusion period, regardless of etiology, including subgroups: sepsis with thrombocytopenia patient cohort and septic shock patient cohort', 'interventionNames': ['Other: No study intervention']}, {'label': 'Sepsis-associated DIC patient cohort', 'description': 'Sepsis patients with onset of DIC in the patient record in patient inclusion period', 'interventionNames': ['Other: No study intervention']}, {'label': 'Non-sepsis-associated DIC patient cohort', 'description': 'DIC patients without sepsis in patient inclusion period', 'interventionNames': ['Other: No study intervention']}], 'interventions': [{'name': 'No study intervention', 'type': 'OTHER', 'description': 'Retrospective observational study using Real World Data (RWD) in Japan without study intervention', 'armGroupLabels': ['Non-sepsis-associated DIC patient cohort', 'Sepsis patient cohort', 'Sepsis-associated DIC patient cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100-8265', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Bayer', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}