Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil
Strasbourg, 67098, France
Not Yet Recruiting
NCT Number: NCT07039487
EVALUATION OF NEUTROPHIL FLUORESCENCE IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Blood sampling collection
OtherCBC 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.
Primary outcomes
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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.
Time frame: 1 month
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.
Secondary outcomes
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To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.
Time frame: 1 month
Sensitivity (Se)
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To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.
Time frame: 1 month
Specificity (Spe)
-
To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.
Time frame: 1 month
Positive Predictive Value (PPV)
-
To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.
Time frame: 1 month
Negative Predictive Value (NPV)
-
To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds.
Time frame: 1 month
Positive and Negative Likelihood Ratios of neutrophil fluorescence measured on a new automaton., at dmission to ICU for all relevant thresholds.
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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
Time frame: 1 month
Area under the partial ROC curve (corresponding to a 90% ≥ Se)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Strasbourg, France
Other
Registry information
Acronym: HEMATOCLOT
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 26, 2025
- Registry last updated
- Jun 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.