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

February 22, 2016 updated by: Pr Bruno LEVY, Central Hospital, Nancy, France
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with septic shock
Biological: blood sampling
additional blood sampling (volume: 18 mL)
Other: Blood samples from a historical cohort of healthy volunteers
Biological: blood sampling
additional blood sampling (volume: 18 mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours
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.
48 hours
Correlation of neutrophil elastase with changes in endogenous thrombin potential
Time Frame: 48 hours
Neutrophil elastase will be measured in plasma from patients.
48 hours
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.
48 hours
Correlation of circulating histones with changes in endogenous thrombin potential
Time Frame: 48 hours
Circulating histones will be measured in plasma from patients
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Diagnostica Stago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00834-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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