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Not yet recruitingNCT07039487HEMATOCLOTUpdated Jun 26, 2025

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

An observational study in DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK, sponsored by University Hospital, Strasbourg, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK
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In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient admitted to intensive care for septic shock

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherBlood sampling collection

    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.

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What researchers measure

Primary outcomes

  1. 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.

    DIC 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.

    Time frame: 1 month

Secondary outcomes

  1. To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.

    Sensitivity (Se)

    Time frame: 1 month

  2. To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.

    Specificity (Spe)

    Time frame: 1 month

  3. To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.

    Positive Predictive Value (PPV)

    Time frame: 1 month

  4. To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.

    Negative Predictive Value (NPV)

    Time frame: 1 month

  5. To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.

    Positive and Negative Likelihood Ratios of neutrophil fluorescence measured on a new automaton., at dmission to ICU for all relevant thresholds.

    Time frame: 1 month

  6. 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 diagnosis

    Area under the partial ROC curve (corresponding to a 90% ≥ Se)

    Time frame: 1 month

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Study locations

1 site
  • Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil
    Strasbourg, 67098, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07039487
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jun 26, 2025

Study contacts

Ferhat MEZIANI, Professor
Contact
ferhat.meziani@chru-strasbourg.fr
+33369551021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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