Skip to main content
OpenTrials
Completed

NCT Number: NCT06986798

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Associated DIC Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin, Innsbruck, Tyrol, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be 18 years of age inclusive, at the time of signing the informed consent.
  • Participants with diagnosed sepsis according to sepsis-3 definition.
  • Participants with documented suspected origin of infection.
  • Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.

Exclusion criteria

  • Patients deferred from other Intensive Care Units (ICUs).
  • Patients longer than 24 hours on ICU.
  • Known coagulation disorder.
  • Ongoing active clinically significant bleeding.
  • Participants experienced trauma or major surgery (within 4 weeks).
  • Active malignancy.
  • Decompensated liver impairment Child-Pugh Class C.
  • Moribund patients not expected to survive 24 hours (clinical decision).
  • Ongoing therapeutic anticoagulation (prophylactic dose of Unfractionated Heparin [UFH]/Low Molecular Weight Heparin [LMWH] is allowed) or antiplatelet therapy (except low dose [≤100 mg] acetyl salicylic acid [ASA]). If previously named treatment can be stopped the participants will be eligible if a "wash out"-time of five half-lives is applied before start of study.
  • Patients who have received any investigational drug involving pharmacological interventions, or biological or cell therapy interventions or prohibited therapy within 28 days or five half-lives, whichever is longer, prior to screening/baseline.
  • Any reason that would make participation unadvisable, at the discretion of the investigator.

Treatment and study plan

Local standard medical care

Other

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.

Primary outcomes

  1. Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria

    Time frame: Until Day 56

    The International Society on Thrombosis and Haemostasis (ISTH) developed a scoring system to aid in the diagnosis and management of DIC. The ISTH DIC score is a standardized tool that quantifies the severity of DIC based on specific laboratory parameters. The total score ranges from 0 to 8, with a score of ≥ 4 indicating overt DIC. In this study, the ISTH DIC score will be employed for screening purposes as well as to evaluate the presence and severity of DIC in participants enrolled.

Secondary outcomes

  1. Sequential Organ Failure Assessment (SOFA) score at baseline

    Time frame: At baseline

    The Sequential Organ Failure Assessment (SOFA) score is a clinical tool used to track a patient's status in regard to the organ systems during stay in an Intensive Care Unit (ICU), assigning a score from 0 (normal function) to 4 (high degree of dysfunction) for each system. The total SOFA can range from 0 to 24.

  2. Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first

    Time frame: Baseline and Day 5 or End of ICU stay

    The Sequential Organ Failure Assessment (SOFA) score is a clinical tool used to track a patient's status in regard to the organ systems during stay in an Intensive Care Unit (ICU), assigning a score from 0 (normal function) to 4 (high degree of dysfunction) for each system. The total SOFA can range from 0 to 24.

  3. All-cause mortality until Day 56

    Time frame: Until Day 56

  4. Type of organ support status until Day 56

    Time frame: Until Day 56

    Describe the type of organ support status.

  5. Time with organ support status until Day 56

    Time frame: Until Day 56

    Describe the time with organ support status.

  6. Type of hospitalization status until Day 56

    Time frame: Until Day 56

    Describe the type of hospitalization (ICU [Intensive Care Unit]/ common ward/ discharge).

  7. Time with hospitalization until Day 56

    Time frame: Until Day 56

    Describe the time with hospitalization.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Exploratory Study to Investigate the Association Between the Onset of Disseminated Intravascular Coagulation (DIC) and Disease Progression With Different Biomarker Candidates as Well as Standard Clinical and Demographic Parameters in Adult Patients With Sepsis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 23, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.