NCT06986798

A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis

Completed NA Last updated 11 February 2026

What this trial tests

NA trial testing Local standard medical care in Sepsis in 150 participants. Completed in 2 February 2026.

Timeline

29 January 2025

Primary endpoint
22 December 2025

2 February 2026

Quick facts

Lead sponsor	Bayer
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	150
Start date	29 January 2025
Primary completion	22 December 2025
Estimated completion	2 February 2026
Sites	31 locations across France, Italy, Netherlands, Belgium, Austria, Germany, Spain

Drugs / interventions tested

• Local standard medical care

Conditions studied

• Sepsis — all drugs for Sepsis →
• Sepsis Associated DIC — all drugs for Sepsis Associated DIC →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Sepsis or Sepsis Associated DIC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an exploratory study in which data from people with sepsis (a serious condition in which the body responds to an infection that damages vital organs) admitted to an Intensive care unit (ICU) who will receive treatment are studied.

Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. Disseminated intravascular coagulation (DIC) is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. DIC is a serious condition that can happen in people with sepsis, which may further lead to organ damage or even death.

No investigational products will be administered in this study. Participants will be treated with the standard of care (SOC) for sepsis. The SOC is the treatment that medical experts consider most appropriate currently.

There are limited treatments available for DIC, especially for people with sepsis and other diseases. To better understand the impact of sepsis, and how it develops into DIC, more knowledge is needed in the European population.

The main purpose of this study is to learn about how sepsis worsens, especially from the time a person is admitted to the ICU until they develop DIC. To do this, researchers will identify certain biomarkers to understand how DIC develops and progresses in people with sepsis. A biomarker is present in blood, other body fluids, or tissues and indicates a disease or abnormal process inside the body.

To learn about this, researchers will collect information about the participants who develop DIC, including cause, and severity of DIC (using a score called ISTH DIC Score). The data will be collected from participants' hospital records in more than three European countries. Each participant will be in the study for up to 56 days. During the study, the doctors and their study team will take blood samples up to 6 times to check for the presence of biomarkers for the identification of people with DIC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.