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

NCT06765681 | Active Not Recruiting

• 1 other identifier: 22892
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Venous Thromboembolism; Disseminated Intravascular Coagulation

Outcome Measures

Primary Outcomes (2)

• Prevalence of diagnosed DIC among hospitalized people with sepsis-associated VTE

  Retrospective analysis of 15 year dataset

• Proportion of undiagnosed DIC among hospitalized people with sepsis-associated VTE

  Based on trajectory of laboratory and vital sign data from the time of sepsis ICD10 coding to the time of VTE coding and to the time of DIC coding

  Retrospective analysis of 15 year dataset

Study Arms (3)

Diagnosed DIC

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

Other: Diagnosis of both VTE and sepsis

Undiagnosed DIC

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

Other: Diagnosis of both VTE and sepsis

No DIC

Patients with no DIC within the same hospital stay

Other: Diagnosis of both VTE and sepsis

Interventions

Diagnosis of both VTE and sepsis OTHER

Both diagnoses need to present during ICU stay for case inclusion into this retrospective study

Diagnosed DIC; No DIC; Undiagnosed DIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

MeSH Terms

Conditions

Sepsis; Venous Thromboembolism; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 9, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)