Platelet-associated Inflammation in Severe Sepsis

Completed

• Conditions: Severe Sepsis
• Interventions: Other: Blood samples

• Registration Number: NCT03029039
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Sepsis represents a serious public health issue characterized by a complex inflammatory response. In addition to their hemostatic role, platelets display inflammatory functions by secreting a variety of immunomodulatory factors and interacting with circulating immune cells. The investigators postulate that, in severe sepsis, platelets become activated and release amounts of different soluble inflammatory molecules that contribute to sepsis-associated inflammation. First, the investigators propose to assess whether severe sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented infection, ICU patients with documented infection involving other bacterial species, compared to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the investigators wish to assess whether the bacterial species affects the release of platelet sCD40L and by an extensive screening of platelet soluble factors, the investigators propose to set up profiles of inflammatory molecules associated with the type of infection. Finally, the investigators will analyze platelets' activation state and their association with circulating immune, according to the type of infection. Therefore, this project is expected to assess to which extent the platelet inflammatory function is super-activated in severe sepsis and to identify new platelet-related biomarkers of sepsis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-24
• Study Start: 2017-02-02
• Primary Completion: 2019-07-05
• Study Completion: 2019-07-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with inflammatory syndrome without sepsis	Blood samples	Blood samples will be collected at inclusion.
patients with severe sepsis	Blood samples	Blood samples will be collected at inclusion.
blood donor voluntary	Blood samples	Blood samples will be collected.

Primary Outcome Measures

Name	Time	Method
Comparison of proportion of CD40L between the 3 groups	1 year	Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between the 3 groups by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).

Secondary Outcome Measures

Name	Time	Method
Comparison of proportion of CD40L between patients with severe sepsis and blood donor voluntary	1 year	Comparison of proportion of CD40L in Platelet poor plasma (PPP) between patients with severe sepsis and blood donor voluntary by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).
Comparison of proportion of CD40Lbetween patients with severe sepsis and patients with inflammatory syndrome without sepsis	1 year	Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between patients with severe sepsis and patients with inflammatory syndrome without sepsis by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).
Proportion of CD40L	1 year	Proportion of CD40L of patients with severe sepsis according to the different infection (S. aureus , S. pneumoniae, E. coli)

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint Etienne, France