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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.

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

MeSH Terms

Conditions

SepsisVenous ThromboembolismDisseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic Diseases

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

Diagnosed DIC

Undiagnosed DIC

No DIC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

Diagnosed DIC

Undiagnosed DIC

No DIC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations