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

SepThrom: Exploring the Relationship Between Sepsis, VTE and DIC in RWD.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sepsis; Venous Thromboembolism; Disseminated Intravascular Coagulation
• Intervention / Treatment: Other: Diagnosis of both VTE and sepsis

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnosed DIC; Patients with ICD10 (International Classification of Diseases) code for DIC	Other: 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	Other: 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	Other: Diagnosis of both VTE and sepsis; Both diagnoses need to present during ICU stay for case inclusion into this retrospective study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Embolism and Thrombosis; Blood Coagulation Disorders; Hemorrhagic Disorders; Thromboembolism; Thrombophilia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Sepsis; Venous Thromboembolism; Disseminated Intravascular Coagulation
• Other Study ID Numbers: 22892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No