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EARLY DIAGNOSIS OF SEPTIC DIC

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07630415
Acronym
EASY-DIC
Enrollment
492
Registered
2026-06-05
Start date
2026-06-15
Completion date
2029-01-15
Last updated
2026-06-05

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

Conditions

Disseminated Intravascular Coagulation (DIC), Reanimation, Septic Shock

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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 resultsFrom admission to intensive care until day 2 after admission1. 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.

Countries

France

Contacts

CONTACTJulie HELMS, Professor
julie.helms@chru-strasbourg.fr+33 3 69 55 13 69

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026