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

This study has been terminated.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00361725
First received: August 7, 2006
Last updated: August 9, 2006
Last verified: June 2006
  Purpose

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
Severe Sepsis
Organ Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparative Study of the Protein C Pathway in Septic and Non Septic Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Estimated Enrollment: 90
Study Start Date: March 2003
Estimated Study Completion Date: October 2003
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361725

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00361725     History of Changes
Other Study ID Numbers: PROCAS
Study First Received: August 7, 2006
Last Updated: August 9, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Protein C
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014