An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
NCT ID: NCT06765681
Last Updated: 2025-11-21
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
10000 participants
OBSERVATIONAL
2025-01-06
2026-03-31
Brief Summary
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In this observational study, only observations are made without participants receiving any advice or changes to their healthcare.
VTE is a condition that occurs when blood clots form in the veins, which can be dangerous. DIC is a serious blood disorder that can cause clots throughout the body, blocking blood flow. People who have sepsis are at a higher risk of developing both VTE and DIC. Researchers wanted to know if people who have sepsis developed DIC before developing VTE.
To prevent VTE in people with sepsis, it is important to know how severe the sepsis is, how it progresses, and whether DIC is also present or not.
In this study, researchers will assess patient data from a medical database in the United States (US).
The main purpose of this study is to learn if there is a relationship between sepsis, DIC, and VTE.
To do this, researchers will divide the participants with VTE due to sepsis into three groups as follows:
* participants who were diagnosed with DIC based on the extent of blood clotting
* participants who likely had DIC but it was not diagnosed
* participants who did not develop DIC during the same hospital visit
The researchers will collect the following information:
* the number of participants who had VTE due to sepsis also had DIC
* the change in participants' laboratory results and vital signs, such as heart rate and blood pressure, from the time their sepsis was diagnosed to the time their VTE and DIC were diagnosed
The researchers will study the data collected between January 2007 and December 2021.
The data will come from the participants' information stored in a database called the Optum VTE EHR which collects patient medical data from hospitals across the US.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Diagnosed DIC
Patients with ICD10 (International Classification of Diseases) code for DIC
Diagnosis of both VTE and sepsis
Both diagnoses need to present during ICU stay for case inclusion into this retrospective study
Undiagnosed DIC
Patients with SIC (Sepsis Induced Coagulopathy) score of \>/= 4
Diagnosis of both VTE and sepsis
Both diagnoses need to present during ICU stay for case inclusion into this retrospective study
No DIC
Patients with no DIC within the same hospital stay
Diagnosis of both VTE and sepsis
Both diagnoses need to present during ICU stay for case inclusion into this retrospective study
Interventions
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Diagnosis of both VTE and sepsis
Both diagnoses need to present during ICU stay for case inclusion into this retrospective study
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* less than 365 days data available prior to index VTE
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Bayer
Whippany, New Jersey, United States
Countries
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Related Links
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Click here for access to information about Bayer's transparency standards and Bayer studies.
Other Identifiers
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22892
Identifier Type: -
Identifier Source: org_study_id
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