Disseminated Intravascular Coagulation (DIC)EASY-DICNCT07630415
EARLY DIAGNOSIS OF SEPTIC DIC
An observational study of Disseminated Intravascular Coagulation (DIC) and Reanimation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disseminated Intravascular Coagulation (DIC), Reanimation, Septic Shock
- How many people
- 492 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2026to 15 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital
Strasbourg, 67098
About this study
Official title: OPTIMIZATION AND CLINICAL VALIDATION OF AN INNOVATIVE TEST FOR THE EARLY DIAGNOSIS OF SEPTIC DIC VIA AN AUTOMATION INTEGRATING ARTIFICIAL INTELLIGENCE
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.
- Medical subject headings
- Disseminated Intravascular Coagulation, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
Measured: From admission to intensive care until day 2 after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated Intravascular Coagulation (DIC)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630415
- Sponsor's protocol ID
- RC26_0023
- Other IDs
- CE-2026-38
- Acronym
- EASY-DIC
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZATION AND CLINICAL VALIDATION OF AN INNOVATIVE TEST FOR THE EARLY DIAGNOSIS OF SEPTIC DIC VIA AN AUTOMATION INTEGRATING ARTIFICIAL INTELLIGENCE
- ClinicalTrials.gov ID
- NCT07630415
- Acronym / sponsor ID
- EASY-DIC / RC26_0023
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Moribund patient on the day of inclusion
- Child-Pugh C cirrhosis
- Neutropenia (<500 mm3)
- Patient under legal protection
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disseminated Intravascular Coagulation (DIC) and Reanimation, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie HELMS, Professor (+33 3 69 55 13 69, julie.helms@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.