Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis
Lead Sponsor:
Bayer
Conditions:
Sepsis
Sepsis Associated DIC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06986798
Start Date
January 29 2025
End Date
January 30 2026
Last Update
December 17 2025
Active Locations (31)
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1
MedUni Graz | Innere Medizin, ICU
Graz, Austria, 8036
2
MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
Innsbruck, Austria, 6020
3
MedUni Wien | Univ. Klinik für Klinische Pharmakologie
Vienna, Austria, 1090
4
AZ Groeninge - Campus Kennedylaan
Kortrijk, Belgium, 8500