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Understanding blood clotting issues in sepsis patients

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

Not applicable Interventional Bayer · NCT06986798

This study is trying to understand how sepsis can cause serious blood clotting problems in ICU patients to help improve treatment options.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorBayer Industry-sponsored
Locations32 sites (Graz and 31 other locations)
Trial IDNCT06986798 on ClinicalTrials.gov

What this trial studies

This exploratory study examines the occurrence of disseminated intravascular coagulation (DIC) in patients diagnosed with sepsis who are admitted to an Intensive Care Unit (ICU). Participants will receive standard medical care for sepsis, and the study aims to gather data on how sepsis can lead to DIC, a serious blood disorder that can cause organ damage. By analyzing this data, the study seeks to improve understanding of the relationship between sepsis and DIC, which currently has limited treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with sepsis according to the sepsis-3 definition.

Not a fit: Patients with known coagulation disorders, ongoing significant bleeding, or those who are moribund and not expected to survive 24 hours will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of sepsis and DIC, potentially leading to better treatment strategies for affected patients.

How similar studies have performed: While there is limited research specifically on DIC in sepsis, studies on sepsis management have shown varying degrees of success, indicating that this area is still being explored.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Graz and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SepsisSepsis Associated DICDIC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.