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Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers (COASEPT)

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ClinicalTrials.gov Identifier: NCT02692053
Recruitment Status : Unknown
Verified February 2016 by Pr Bruno LEVY, Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Diagnostica Stago
Information provided by (Responsible Party):
Pr Bruno LEVY, Central Hospital, Nancy, France

Study Description
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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.

Condition or disease Intervention/treatment Phase
Septic Shock Biological: blood sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with septic shock Biological: blood sampling
additional blood sampling (volume: 18 mL)
Blood samples from a historical cohort of healthy volunteers Biological: blood sampling
additional blood sampling (volume: 18 mL)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in Thrombin peak 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. 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.

  2. Changes in clot lysis time as assessed by clot lysis assay [ Time Frame: 48 hours ]
    Clot lysis assay will, be performed in plasma from patients and will be compared with those obtained in healthy subjects.

  3. Correlation of neutrophil elastase with changes in endogenous thrombin potential [ Time Frame: 48 hours ]
    Neutrophil elastase will be measured in plasma from patients.

  4. Correlation of cell-derived microparticles with changes in endogenous thrombin potential [ Time Frame: 48 hours ]
    microparticles derived from leukocytes, erythrocytes, platelets and endothelial cells will be measured in plasma from patients by flow cytometry.

  5. Correlation of circulating histones with changes in endogenous thrombin potential [ Time Frame: 48 hours ]
    Circulating histones will be measured in plasma from patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692053


Contacts
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Contact: Bruno MI LEVY, PhD blevy5463@gmail.com

Sponsors and Collaborators
Central Hospital, Nancy, France
Diagnostica Stago
More Information
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Responsible Party: Pr Bruno LEVY, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02692053    
Other Study ID Numbers: 2015-A00834-45
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
 Infections
Systemic Inflammatory Response Syndrome
Inflammation