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

Not Applicable

• Conditions: Septic Shock
• Interventions: Biological: blood sampling

• Registration Number: NCT02692053
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Study First Posted: 2016-02-25
• Last Update Posted: 2016-02-25
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood samples from a historical cohort of healthy volunteers	blood sampling	-
Patients with septic shock	blood sampling	-

Primary Outcome Measures

Name	Time	Method
Changes in endogenous thrombin potential as assessed by thrombin generation test	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

Name	Time	Method
Correlation of neutrophil elastase with changes in endogenous thrombin potential	48 hours	Neutrophil elastase will be measured in plasma from patients.
Correlation of cell-derived microparticles with changes in endogenous thrombin potential	48 hours	microparticles derived from leukocytes, erythrocytes, platelets and endothelial cells will be measured in plasma from patients by flow cytometry.
Changes in Thrombin peak as assessed by thrombin generation test	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.
Changes in clot lysis time as assessed by clot lysis assay	48 hours	Clot lysis assay will, be performed in plasma from patients and will be compared with those obtained in healthy subjects.
Correlation of circulating histones with changes in endogenous thrombin potential	48 hours	Circulating histones will be measured in plasma from patients