EARLY DIAGNOSIS OF SEPTIC DIC

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.

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Key information

Conditions

Disseminated Intravascular Coagulation (DIC) Blood Coagulation Disorders Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Reanimation Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female ≥ 18 years old
Patient admitted to intensive care for septic shock
Patient affiliated with a social security scheme or having rights
No objection from the patient or a relative in case the patient is not able to express consent, or inclusion under emergency procedure in case the patient is not able to express their opinion and no relative of the patient is reachable.

Exclusion criteria

Moribund patient on the day of inclusion
Child-Pugh C cirrhosis
Neutropenia (<500 mm3)
Patient under legal protection
Patient under guardianship or curatorship
Pregnancy/ Breastfeeding

Treatment and study plan

Primary outcomes

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

Time frame: From admission to intensive care until day 2 after admission
- 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.
- 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie HELMS, Professor

CONTACT

[email protected]

+33 3 69 55 13 69

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

OPTIMIZATION AND CLINICAL VALIDATION OF AN INNOVATIVE TEST FOR THE EARLY DIAGNOSIS OF SEPTIC DIC VIA AN AUTOMATION INTEGRATING ARTIFICIAL INTELLIGENCE

Acronym: EASY-DIC

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jun 5, 2026
Registry last updated: Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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