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

Septic Shock Clinical Trial

— COASEPT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02692053
• Other study ID #: 2015-A00834-45
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2016
• Last updated: February 22, 2016
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2016
• Source: Central Hospital, Nancy, France
• Contact: Bruno MI LEVY, PhD
• Email: blevy5463[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Biological:
• blood sampling
additional blood sampling (volume: 18 mL)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Diagnostica Stago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours	No
Secondary	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.	48 hours	No
Secondary	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.	48 hours	No
Secondary	Correlation of neutrophil elastase with changes in endogenous thrombin potential	Neutrophil elastase will be measured in plasma from patients.	48 hours	No
Secondary	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.	48 hours	No
Secondary	Correlation of circulating histones with changes in endogenous thrombin potential	Circulating histones will be measured in plasma from patients	48 hours	No