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

Launched by BAYER · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how a serious condition called sepsis can lead to another dangerous issue known as disseminated intravascular coagulation (DIC). Sepsis occurs when the body has a severe reaction to an infection, which can damage vital organs. DIC is a blood disorder that can cause harmful blood clots throughout the body. The researchers want to understand how sepsis worsens and how it can lead to DIC by studying patients admitted to Intensive Care Units (ICUs) across Europe. Participants will receive standard care for sepsis, and the study will involve collecting medical information and blood samples to identify specific markers that indicate the development of DIC.

To join the study, participants must be at least 18 years old and diagnosed with sepsis. They should have a documented source of infection. However, certain individuals may not be eligible, such as those with bleeding disorders or recent major surgeries. During the study, each participant will be monitored for up to 56 days, and doctors will take blood samples several times to check for these important markers. This research is crucial to improve our understanding of sepsis and DIC, especially in European patients.

Gender

ALL

Eligibility criteria

• 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.