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EVALUATION OF NEUTROPHIL FLUORESCENCE IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK

EVALUATION OF NEUTROPHIL FLUORESCENCE IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07039487
Acronym
HEMATOCLOT
Enrollment
100
Registered
2025-06-26
Start date
2025-07-01
Completion date
2027-08-01
Last updated
2025-06-26

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

Conditions

DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK

Brief summary

Neutrophil fluorescence could be a reliable and early diagnostic marker of disseminated intravascular coagulation septic DIC, which can be used routinely. The objective of the investigators is to define the optimal threshold of neutrophil fluorescence associated with a sensitivity of at least 90% for the diagnosis of DIC.

Interventions

CBC performed on the background of an EDTA tube, collected routinely allowing neutrophil fluorescence measurements. This tube will then be passed over on the automaton for a CBC measurement with leukocyte differentiation.

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 of age * Patient admitted to intensive care for septic shock * Patient affiliated to a social security scheme or entitled to it * Non-opposition by the patient or a relative in the event that the patient is not in a state to express his or her consent or inclusion in an emergency procedure in the event that the patient is not in a state to express his or her opinion and no relative of the patient can be reached.

Exclusion criteria

* Dying patient on the day of inclusion * Cirrhosis Child Pugh C * Neutropenia (\<500 mm3) * Patient under judicial protection * Patient under guardianship or curatorship * Pregnancy * Breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Define the optimal threshold for neutrophil fluorescence (measured at admission of the patient to intensive care on a new automaton) associated with a sensitivity of at least 90% for the diagnosis of disseminated intravascular coagulation DIC.1 monthDIC is diagnosed based on the ISTH score (reference diagnosis) on day 2: patients will be considered to have DIC if the score is positive within the first 48 hours after admission to the ICU. Neutrophil fluorescence is measured on a new automaton.

Secondary

MeasureTime frameDescription
To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.1 monthSensitivity (Se)
To compare the areas under the partial ROC (receiver operating characteristic) curve (for a sensitivity greater than or equal to 90%) illustrating the performance of neutrophil fluorescence measured at the patient's admission to the ICU in the diagnosis1 monthArea under the partial ROC curve (corresponding to a 90% ≥ Se)

Countries

France

Contacts

Primary ContactFerhat MEZIANI, Professor
ferhat.meziani@chru-strasbourg.fr+33369551021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026