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

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Septic Shock

Treatments

Biological: blood sampling

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02692053
2015-A00834-45

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Patients with septic shock
Experimental group
Treatment:
Biological: blood sampling
Blood samples from a historical cohort of healthy volunteers
Other group
Treatment:
Biological: blood sampling

Trial contacts and locations

0

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Central trial contact

Bruno MI LEVY, PhD

Data sourced from clinicaltrials.gov

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