NCT00361725TerminatedNot Applicable
Comparative Study of the Protein C Pathway in Septic and Non Septic Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 90
Study Overview
Brief Summary
This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects.
The only intervention is a venous blood sampling at the onset of the disease.
The purpose of the study is to compare the PC pathway and expression and inflammatory genes between the 3 groups. The main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.
Detailed Description
analysis of the PC pathway
- PC activity
- PS activity
- soluble thrombomodulin
- soluble EPCR
- activated protein C
- quantitative flow cytometry on monocytes (thrombomodulin and EPCR)
- whole blood mRNA (Tissue factor, thrombomodulin and EPCR)
- inflammatory gene expression analysis by MLPA
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •severe sepsis patients or:
- •non-septic acute organ failure patients or:
- •healthy subjects matched for age and sex with severe sepsis patients
Exclusion Criteria
- •criteria for organ failure lasting for more than 24 hours
Investigators
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