SepsisNCT06765681
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
An observational study of Sepsis and Venous Thromboembolism, run by Bayer at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Venous Thromboembolism, Disseminated Intravascular Coagulation
- What is being tested?
- Diagnosis of both VTE and sepsis
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 30 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- admitted to an ICU with the diagnosis of VTE and sepsis during the same hospital ICU admission
Who cannot join
- less than 18 yrs old
- less than 365 days data available prior to index VTE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Diagnosis of both VTE and sepsis
- Medical subject headings
- Sepsis, Venous Thromboembolism, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of both VTE and sepsisOther
Both diagnoses need to present during ICU stay for case inclusion into this retrospective study
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed DIC | Patients with ICD10 (International Classification of Diseases) code for DIC Receives: Other: Diagnosis of both VTE and sepsis | |
| Undiagnosed DIC | Patients with SIC (Sepsis Induced Coagulopathy) score of >/= 4 Receives: Other: Diagnosis of both VTE and sepsis | |
| No DIC | Patients with no DIC within the same hospital stay Receives: Other: Diagnosis of both VTE and sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diagnosed DIC among hospitalized people with sepsis-associated VTE
Measured: 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
Measured: Retrospective analysis of 15 year dataset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start6 Jan 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765681
- Sponsor's protocol ID
- 22892
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.