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Comparative Study of the Protein C Pathway in Septic and Non Septic Patients With Organ Failure

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ClinicalTrials.gov Identifier: NCT00361725
Recruitment Status : Terminated
First Posted : August 8, 2006
Last Update Posted : August 15, 2006
Information provided by:

Study Description
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.

Condition or disease
Severe Sepsis Organ Failure

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
Estimated Enrollment : 90 participants
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Comparative Study of the Protein C Pathway in Septic and Non Septic Patients
Study Start Date : March 2003
Estimated Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361725

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Jean-Luc DIEHL, MD Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00361725     History of Changes
Other Study ID Numbers: PROCAS
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: June 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
severe sepsis
organ failure
activated protein C

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Protein C
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action