DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCKHEMATOCLOTNCT07039487
EVALUATION OF NEUTROPHIL FLUORESCENCE IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK
An observational study of DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK
- What is being tested?
- Blood sampling collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 1 Aug 2027
- 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: Patient admitted to intensive care for septic shock
Who may be able to join
- 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.
Who cannot join
- 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
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
Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil
Strasbourg, 67098
About this study
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.
- Being tested
- Blood sampling collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling collectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Sensitivity (Se)
Measured: 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.
Specificity (Spe)
Measured: 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.
Positive Predictive Value (PPV)
Measured: 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.
Negative Predictive Value (NPV)
Measured: 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.
Positive and Negative Likelihood Ratios of neutrophil fluorescence measured on a new automaton., at dmission to ICU for all relevant thresholds.
Measured: 1 month
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (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 ASSOCIATED WITH SEPTIC SHOCKStudies 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
- 100 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
- NCT07039487
- Sponsor's protocol ID
- 9556
- Other IDs
- 2024-A02853-44
- Acronym
- HEMATOCLOT
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF NEUTROPHIL FLUORESCENCE IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK
- ClinicalTrials.gov ID
- NCT07039487
- Acronym / sponsor ID
- HEMATOCLOT / 9556
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Jun 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to intensive care for septic shock
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Dying patient on the day of inclusion
- Cirrhosis Child Pugh C
- Neutropenia (<500 mm3)
- Patient under judicial 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling collectionCBC 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. | Other | – |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
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 26 Jun 2025.
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 ASSOCIATED WITH SEPTIC SHOCK, 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 7 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 26 Jun 2025. 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 Ferhat MEZIANI, Professor (+33369551021, ferhat.meziani@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 26 Jun 2025.