EARLY DIAGNOSIS OF SEPTIC DIC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Moribund patient on the day of inclusion
Child-Pugh C cirrhosis
Neutropenia (<500 mm3)
Patient under legal protection
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
492 Participants
are grouped into 1 trial groupGroup A: Patients admitted to intensive care for septic shock
Trial outcomes
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.
Time frame
From admission to intensive care until day 2 after admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: