CClinicalTrials.gg
Status unknownNCT02692053COASEPTUpdated Feb 25, 2016

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

An interventional study of blood sampling in Septic Shock, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Septic Shock
03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria for patients with septic schock

Inclusion criteria

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients with septic shock

    Biological: blood sampling

  • Other
    Blood samples from a historical cohort of healthy volunteers

    Biological: blood sampling

Interventions

  • Biologicalblood sampling

    additional blood sampling (volume: 18 mL)

06

What researchers measure

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

    Time frame: 48 hours

Secondary outcomes

  1. 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.

    Time frame: 48 hours

  2. 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.

    Time frame: 48 hours

  3. Correlation of neutrophil elastase with changes in endogenous thrombin potential

    Neutrophil elastase will be measured in plasma from patients.

    Time frame: 48 hours

  4. 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.

    Time frame: 48 hours

  5. Correlation of circulating histones with changes in endogenous thrombin potential

    Circulating histones will be measured in plasma from patients

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02692053
Lead sponsor
Central Hospital, Nancy, France
Collaborators
Diagnostica Stago
Responsible party
Pr Bruno LEVY (Professor, Central Hospital, Nancy, France) — Principal investigator
First posted
Feb 25, 2016
Start date
Feb 2016
Primary completion
Feb 2018 (estimated)
Completion
Feb 2018 (estimated)
Last update
Feb 25, 2016

Study contacts

Bruno MI LEVY, PhD
Contact
blevy5463@gmail.com
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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