Clinical trial NCT06765681: An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Official title: SepThrom: Exploring the Relationship Between Sepsis, VTE and DIC in RWD.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sepsis
Venous Thromboembolism
Disseminated Intravascular Coagulation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All inpatients admitted to an ICU with the diagnosis of VTE and sepsis during the same hospital ICU admission, within the Optum VTE EHR dataset from 1 January 2007 to 31 December 2021

Brief summary: This is an observational study in which data already collected from people with venous thromboembolism (VTE) due to sepsis (blood poisoning) are studied. These people were hospitalized in an intensive care unit (ICU) and may or may not have had disseminated intravascular coagulation (DIC).

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.


Eligibility criteria: Inclusion Criteria:

* admitted to an ICU with the diagnosis of VTE and sepsis during the same hospital ICU admission

Exclusion Criteria:

* less than 18 yrs old
* less than 365 days data available prior to index VTE

Primary outcomes:
measure: Prevalence of diagnosed DIC among hospitalized people with sepsis-associated VTE
timeFrame: Retrospective analysis of 15 year dataset
measure: Proportion of undiagnosed DIC among hospitalized people with sepsis-associated VTE
timeFrame: Retrospective analysis of 15 year dataset
Secondary outcomes:
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: