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

NCT ID: NCT02692053

Last Updated: 2016-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-02-28

Brief Summary

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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

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Conditions

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Septic Shock

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with septic shock

Group Type EXPERIMENTAL

blood sampling

Intervention Type BIOLOGICAL

additional blood sampling (volume: 18 mL)

Blood samples from a historical cohort of healthy volunteers

Group Type OTHER

blood sampling

Intervention Type BIOLOGICAL

additional blood sampling (volume: 18 mL)

Interventions

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blood sampling

additional blood sampling (volume: 18 mL)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diagnostica Stago

INDUSTRY

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Pr Bruno LEVY

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Bruno MI LEVY, PhD

Role: CONTACT

Other Identifiers

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2015-A00834-45

Identifier Type: -

Identifier Source: org_study_id

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