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

NCT02692053 | Unknown

• 1 other identifier: 2015-A00834-45
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Changes in Thrombin peak as assessed by thrombin generation test

  48 hours

• Changes in clot lysis time as assessed by clot lysis assay

  48 hours

• Correlation of neutrophil elastase with changes in endogenous thrombin potential

  48 hours

• Correlation of cell-derived microparticles with changes in endogenous thrombin potential

  48 hours

• Correlation of circulating histones with changes in endogenous thrombin potential

  48 hours

Study Arms (2)

Patients with septic shock

EXPERIMENTAL

Biological: blood sampling

Blood samples from a historical cohort of healthy volunteers

OTHER

Biological: blood sampling

Interventions

blood sampling BIOLOGICAL

additional blood sampling (volume: 18 mL)

Blood samples from a historical cohort of healthy volunteers; Patients with septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• septic shock (Dellinger, 2013)
• age \>18y
• hospitalized patients
• signature of an informed consent (emergency consent)
• affiliation to a social security regimen

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Diagnostica Stago: collaborator

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Bruno MI LEVY, PhD

CONTACT

blevy5463@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 25, 2016

Record last verified: 2016-02