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.

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. - Study on DIC and disease progression in sepsis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57271

Enrollment

Registered

2025-01-23

Start date

2025-03-17

Completion date

Unknown

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Participant must be 18 years of age inclusive, at the time of signing the informed consent. 2. Participants with diagnosed sepsis according to sepsis-3 definition. 3. Participants with documented suspected origin of infection.

Exclusion criteria

Exclusion criteria: 1. Patients deferred from other ICUs 2. Patients longer than 24 hours on ICU 3. Known coagulation disorder 4. Ongoing active clinically significant bleeding 5. Participants experienced trauma or major surgery (within 4 weeks) 6. Active malignancy 7. Decompensated liver impairment Child-Pugh Class C 8. Moribund patients not expected to survive 24 hours (clinical decision) 9. Ongoing therapeutic anticoagulation (prophylactic dose of UFH/LMWH is allowed) or antiplatelet therapy (except low dose [

Design outcomes

Primary

Measure	Time frame
Primary objective: Quantification and assessment of the association of (combinations of) biomarkers and standard clinical and demographic characteristics with the (non-) occurrence of DIC. Both baseline levels as well as the longitudinal development of such markers will be of interest. Primary endpoint: Occurrence of DIC as defined by ISTH criteria.	—

Secondary

Measure	Time frame
Secondary objective: Quantification and assessment of the association of (combinations of) biomarkers and standard clinical and demographic characteristics with a range of ICU related clinical endpoints. Both baseline levels as well as the longitudinal development of such markers will be of interest. Secondary endpoints: • SOFA score at baseline • SOFA score (change from baseline on Day 5 or End of ICU stay, whichever happens first) • All-cause mortality until Day 56 • Organ support status until Day 56 • Hospitalization status until Day 56	—

Measure

Time frame

Secondary objective: Quantification and assessment of the association of (combinations of) biomarkers and standard clinical and demographic characteristics with a range of ICU related clinical endpoints. Both baseline levels as well as the longitudinal development of such markers will be of interest. Secondary endpoints: • SOFA score at baseline • SOFA score (change from baseline on Day 5 or End of ICU stay, whichever happens first) • All-cause mortality until Day 56 • Organ support status until Day 56 • Hospitalization status until Day 56

—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Spain

Contacts

Public ContactK Klooster

Bayer

clinical-trials-contact@bayer.com+4930300139003

Outcome results