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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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 12, 2016
    Last Updated
    February 22, 2016
    Sponsor
    Central Hospital, Nancy, France
    Collaborators
    Diagnostica Stago
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    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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