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

NCT07039487 | Not Yet Recruiting

• 2 other identifiers: 95562024-A02853-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK

Outcome Measures

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.

  1 month

Secondary Outcomes (6)

• 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 month

• 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 month

• 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 month

• 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 month

• 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 month

Interventions

Blood sampling collection OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient admitted to intensive care for septic shock

You may qualify if:

• 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

You may not qualify if:

• Cirrhosis Child Pugh C
• Neutropenia (\<500 mm3)
• Patient under judicial protection
• Patient under guardianship or curatorship
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil

Strasbourg, 67098, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling collection

Central Study Contacts

Ferhat MEZIANI, Professor

CONTACT

+33369551021; ferhat.meziani@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

FR (1)