An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related

Bayer

Status: Active, not recruiting

Conditions: Venous Thromboembolism; Disseminated Intravascular Coagulation; Sepsis

Treatments: Other: Diagnosis of both VTE and sepsis

Study type: Observational

Funder types: Industry

Identifiers

NCT06765681

22892

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 3 patient groups

Diagnosed DIC

Description:

Patients with ICD10 (International Classification of Diseases) code for DIC

Treatment:

Other: Diagnosis of both VTE and sepsis

Undiagnosed DIC

Description:

Patients with SIC (Sepsis Induced Coagulopathy) score of \>/= 4

Treatment:

Other: Diagnosis of both VTE and sepsis

No DIC

Description:

Patients with no DIC within the same hospital stay

Treatment:

Other: Diagnosis of both VTE and sepsis