Understanding blood clotting issues in sepsis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
  Innsbruck, Austria Recruiting
• AZ Groeninge - Campus Kennedylaan
  Kortrijk, Belgium Recruiting
• Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
  Liège, Belgium Recruiting
• Clinique Saint-Pierre d'Ottignies - Intensive Care
  Ottignies-Louvain-La-Neuve, Belgium Recruiting
• Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
  Angers, France Recruiting
• Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
  Limoges, France Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.