Trials Sponsors Conditions Drugs Pricing

Conditions

Disseminated Intravascular Coagulation (DIC)Reanimation Septic Shock

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

University Hospital, Strasbourg, France
Otherlead

Study Sites (1)

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

Strasbourg, 67098, France

MeSH Terms

Conditions

Disseminated Intravascular CoagulationShock, Septic

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophiliaSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 15, 2028

Estimated

EARLY DIAGNOSIS OF SEPTIC DIC

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients admitted to intensive care for septic shock

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients admitted to intensive care for septic shock

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations