Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers (COASEPT)
Primary Purpose
Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Septic Shock
Eligibility Criteria
Eligibility criteria for patients with septic schock
Inclusion Criteria:
- septic shock (Dellinger, 2013)
- age >18y
- hospitalized patients
- signature of an informed consent (emergency consent)
- affiliation to a social security regimen
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patients with septic shock
Blood samples from a historical cohort of healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Correlation of neutrophil elastase with changes in endogenous thrombin potential
Neutrophil elastase will be measured in plasma from patients.
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.
Correlation of circulating histones with changes in endogenous thrombin potential
Circulating histones will be measured in plasma from patients
Full Information
NCT ID
NCT02692053
First Posted
February 12, 2016
Last Updated
February 22, 2016
Sponsor
Central Hospital, Nancy, France
Collaborators
Diagnostica Stago
1. Study Identification
Unique Protocol Identification Number
NCT02692053
Brief Title
Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
Acronym
COASEPT
Official Title
Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Diagnostica Stago
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with septic shock
Arm Type
Experimental
Arm Title
Blood samples from a historical cohort of healthy volunteers
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
blood sampling
Intervention Description
additional blood sampling (volume: 18 mL)
Primary Outcome Measure Information:
Title
Changes in endogenous thrombin potential as assessed by thrombin generation test
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Changes in Thrombin peak as assessed by thrombin generation test
Description
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.
Time Frame
48 hours
Title
Changes in clot lysis time as assessed by clot lysis assay
Description
Clot lysis assay will, be performed in plasma from patients and will be compared with those obtained in healthy subjects.
Time Frame
48 hours
Title
Correlation of neutrophil elastase with changes in endogenous thrombin potential
Description
Neutrophil elastase will be measured in plasma from patients.
Time Frame
48 hours
Title
Correlation of cell-derived microparticles with changes in endogenous thrombin potential
Description
microparticles derived from leukocytes, erythrocytes, platelets and endothelial cells will be measured in plasma from patients by flow cytometry.
Time Frame
48 hours
Title
Correlation of circulating histones with changes in endogenous thrombin potential
Description
Circulating histones will be measured in plasma from patients
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility criteria for patients with septic schock
Inclusion Criteria:
septic shock (Dellinger, 2013)
age >18y
hospitalized patients
signature of an informed consent (emergency consent)
affiliation to a social security regimen
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno MI LEVY, PhD
Email
blevy5463@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
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