EARLY DIAGNOSIS OF SEPTIC DIC

NCT07630415 | Not Yet Recruiting

• 2 other identifiers: RC26_0023CE-2026-38
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

Brief Summary

Disseminated Intravascular Coagulation is a severe complication of septic shock, associated with high mortality, whose diagnosis relies on complex scores that are rarely used in practice. Preliminary studies have shown that increased neutrophil fluorescence is associated with Disseminated Intravascular Coagulation and could reflect NETosis, a key mechanism of immunothrombosis. This study aims to validate neutrophil fluorescence measured on the SthemA 801 analyzer, alone or integrated into an artificial intelligence model, as an early, reliable, and routinely usable biomarker for the diagnosis of septic Disseminated Intravascular Coagulation.

Conditions

Reanimation; Septic Shock; Disseminated Intravascular Coagulation (DIC)

Outcome Measures

Primary Outcomes (1)

• Early diagnosis of disseminated intravascular coagulation in patients with septic shock hospitalized in medical intensive care using the neutrophil fluorescence ratio or an AI model based on complete blood count results

  1. Development and validation of the optimal neutrophil fluorescence threshold/ratio on the sthemA 801 analyzer for the early diagnosis of septic DIC in patients with septic shock admitted to medical intensive care. 2. Development and validation of the AI model, based on the results of the CBC combined with the advanced multiparametric capabilities of the sthemA 801 analyzer, for the early diagnosis of septic DIC in patients with septic shock admitted to medical intensive care.

  From admission to intensive care until day 2 after admission

Study Arms (1)

Patients admitted to intensive care for septic shock

This pilot cohort is based on the demonstration that the increase in fluorescence of neutrophils, whether isolated or integrated into an AI model, is predictive of DIC and constitutes an early and reliable diagnostic marker of septic DIC.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the intensive care unit (ICU) for septic shock, with or without sepsis-associated disseminated intravascular coagulation (DIC), at the time of ICU admission.

You may qualify if:

• Male or female ≥ 18 years old
• Patient admitted to intensive care for septic shock
• Patient affiliated with a social security scheme or having rights

You may not qualify if:

• Child-Pugh C cirrhosis
• Neutropenia (\<500 mm3)
• Patient under legal protection
• Patient under guardianship or curatorship
• Pregnancy/ Breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Disseminated Intravascular Coagulation; Shock, Septic

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Julie HELMS, Professor

CONTACT

+33 3 69 55 13 69; julie.helms@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

FR (1)