An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
NCT ID: NCT06373159
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
5740 participants
OBSERVATIONAL
2024-03-22
2025-12-31
Brief Summary
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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 DIC
Researchers 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Sepsis patient cohort
Patients diagnosed with sepsis in patient inclusion period, regardless of etiology, including subgroups: sepsis with thrombocytopenia patient cohort and septic shock patient cohort
No study intervention
Retrospective observational study using Real World Data (RWD) in Japan without study intervention
Sepsis-associated DIC patient cohort
Sepsis patients with onset of DIC in the patient record in patient inclusion period
No study intervention
Retrospective observational study using Real World Data (RWD) in Japan without study intervention
Non-sepsis-associated DIC patient cohort
DIC patients without sepsis in patient inclusion period
No study intervention
Retrospective observational study using Real World Data (RWD) in Japan without study intervention
Interventions
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No study intervention
Retrospective observational study using Real World Data (RWD) in Japan without study intervention
Eligibility Criteria
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Inclusion Criteria
* Sepsis patients
* Age ≥18 years
* Subgroups:
* Sepsis with thrombocytopenia patient cohort
* Septic shock patient cohort
* Sepsis-associated DIC patient cohort
* DIC patients in sepsis patient cohort
* Subgroups:
* Organ failure: kidney (Serum creatinine (SCr) \< 1.2 mg/dl and ≥ 1.2 mg/dl)
* Organ failure: liver (bilirubin \< 1.2 mg/dl and ≥ 1.2 mg/dl)
* Organ failure: cardiovascular (with and without catecholamine or vasopressin)
* With low molecular weight (LMW) heparins, unfractionated heparins, and both
* With and without DIC treatment
* Priority 1\_Anticoagulants specifically used in Japan (recombinant antithrombin, recombinant thrombomodulin, human anti-thrombin III)
* Priority 1 + Priority 2\_Drugs for sepsis-associated DIC (LMW heparins, unfractionated heparins, protease inhibitors)
* Priority 1 + Priority 2 + Priority 3\_antibiotics (antifungals), and/or steroids
* Non-sepsis-associated DIC patient cohort
* Hematopoietic malignant tumor patients
* DIC patients
* Age ≥18 years
Exclusion Criteria
* Sepsis-associated DIC patient cohort: None
* Non-sepsis-associated DIC patient cohort: Sepsis patients
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Bayer
Tokyo, , Japan
Countries
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Related Links
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Other Identifiers
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22643
Identifier Type: -
Identifier Source: org_study_id