Septic ShockCOASEPTNCT02692053
Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
A study testing blood sampling in people with Septic Shock, run by Central Hospital, Nancy, France.
Trial summary
Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- septic shock (Dellinger, 2013)
- age >18y
- hospitalized patients
- signature of an informed consent (emergency consent)
- affiliation to a social security regimen
Who cannot join
- pregnancy or breast-feeding women
- moribund patient
- oral anticoagulant therapy
- thrombophilia
- Minor patients
- Patients under tutelage
- Eligibility criteria from subject without septic shock Subject blood samples without septic shock are collected from a historical healthy volunteers cohort.
Trial locations and contacts
No sites are listed yet.
Bruno MI LEVY, PhD contact
About this study
Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. This instability of hemostatic system is not revealed by classical tests. Thus, a better characterization of hemostatic status could certainly improve patient care. This study aims at characterizing disorders of coagulation and fibrinolysis using "global" tests such as thrombin generation test or coagulolytic test. Furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.
- Conditions
- Septic Shock
- Being tested
- blood sampling
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
additional blood sampling (volume: 18 mL)
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic shock | Experimental | Not described Receives: Biological: blood sampling |
| Blood samples from a historical cohort of healthy volunteers | Other | Not described Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endogenous thrombin potential as assessed by thrombin generation test
thrombin generation will be measured using CAT method (fluorescence) in plasma from patients within 48 hours. Endogenous thrombin potential is defined as the area under the thrombin generation curve and will be compared with values obtained in healthy subjects
Measured: 48 hours
Secondary outcomes (5)
Changes in Thrombin peak as assessed by thrombin generation test
thrombin generation will be measured using CAT method (fluorescence) in plasma from patients within 48 hours. Thrombin peak is defined as the highest thrombin concentration derived from the thrombin generation curve and will be compared with values obtained in healthy subjects.
Measured: 48 hours
Changes in clot lysis time as assessed by clot lysis assay
Clot lysis assay will, be performed in plasma from patients and will be compared with those obtained in healthy subjects.
Measured: 48 hours
Correlation of neutrophil elastase with changes in endogenous thrombin potential
Neutrophil elastase will be measured in plasma from patients.
Measured: 48 hours
Correlation of cell-derived microparticles with changes in endogenous thrombin potential
microparticles derived from leukocytes, erythrocytes, platelets and endothelial cells will be measured in plasma from patients by flow cytometry.
Measured: 48 hours
Correlation of circulating histones with changes in endogenous thrombin potential
Circulating histones will be measured in plasma from patients
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Diagnostica Stago
- Responsible party
- Principal investigator, Pr Bruno LEVY, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692053
- Sponsor's protocol ID
- 2015-A00834-45
- Acronym
- COASEPT
- Status last verified
- Feb 2016
- First submitted
- 12 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
- ClinicalTrials.gov ID
- NCT02692053
- Acronym / sponsor ID
- COASEPT / 2015-A00834-45
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Diagnostica Stago
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- 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.
Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. This instability of hemostatic system is not revealed by classical tests. Thus, a better characterization of hemostatic status could certainly improve patient care. This study aims at characterizing disorders of coagulation and fibrinolysis using "global" tests such as thrombin generation test or coagulolytic test. Furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with septic shock | Experimental | Biological: blood sampling |
| Blood samples from a historical cohort of healthy volunteers | Other | Biological: blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- septic shock (Dellinger, 2013)
- age >18y
- hospitalized patients
- signature of an informed consent (emergency consent)
- affiliation to a social security regimen
Key exclusion criteria (7 listed)
- pregnancy or breast-feeding women
- moribund patient
- oral anticoagulant therapy
- thrombophilia
- Minor patients
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 samplingadditional blood sampling (volume: 18 mL) | Biological | Blood samples from a historical cohort of healthy volunteers, Patients with septic shock |
Primary outcome
Changes in endogenous thrombin potential as assessed by thrombin generation test
Time frame: 48 hours
thrombin generation will be measured using CAT method (fluorescence) in plasma from patients within 48 hours. Endogenous thrombin potential is defined as the area under the thrombin generation curve and will be compared with values obtained in healthy subjects
5 secondary outcomes
Changes in Thrombin peak as assessed by thrombin generation test
Time frame: 48 hours
Changes in clot lysis time as assessed by clot lysis assay
Time frame: 48 hours
Correlation of neutrophil elastase with changes in endogenous thrombin potential
Time frame: 48 hours
Correlation of cell-derived microparticles with changes in endogenous thrombin potential
Time frame: 48 hours
Correlation of circulating histones with changes in endogenous thrombin potential
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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Sepsis
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. This study is not recruiting at the moment.
Bruno MI LEVY, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Septic Shock, run by Central Hospital, Nancy, 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 5 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: status not confirmed, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno MI LEVY, PhD (blevy5463@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in endogenous thrombin potential as assessed by thrombin generation test (time frame: 48 hours). 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 25 Feb 2016.