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

StatusActive, Not Recruiting
PhaseNot specified
SponsorBayer
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Aug 31, 2026 → Apr 30, 2027
See other at-risk trials from Bayer

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Aug 31, 2026 to Apr 30, 2027
    • Eligibility criteria expanded, about 3 words
  2. Minor Primary and study completion pushed from Apr 30, 2026 to Aug 31, 2026v11
  3. Minor Primary and study completion pushed from Mar 31, 2026 to Apr 30, 2026v10
  4. Minor Re-verified, no change to tracked fieldsv9
  5. Notable Primary and study completion dates: Sep 30, 2025 to Mar 31, 2026v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Primary and study completion dates: Jun 30, 2025 to Sep 30, 2025v7
  2. Minor 2 versions Re-verified since May 2, 2025, no change to tracked fieldsv5-v6
  3. Minor Primary and study completion dates: Mar 31, 2025 to Jun 30, 2025v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Minor Trial status: Not Yet Recruiting to Active, Not Recruitingv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
131 trials monitored
See 11 trials at risk
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.
Trial Details
NCT Number NCT06765681
Lead Sponsor Bayer
Conditions
(from sponsor)
Sepsis, Venous Thromboembolism, Disseminated Intravascular Coagulation
Related terms Disseminated Intravascular Coagulation, Sepsis, Venous Thromboembolism
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov