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

NCT06986798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Sepsis
  • Sepsis Associated DIC

Interventions

OTHER

Local standard medical care

No investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood and of available clinical data are the only activities performed in addition.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2025-12-22
Completion
2026-05-06

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06986798 on ClinicalTrials.gov