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

This study has been terminated.

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00361725

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

MedlinePlus related topics: Sepsis

Drug Information available for: Protein C

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Case Control, Prospective Study
Official Title:	Comparative Study of the Protein C Pathway in Septic and Non Septic Patients

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

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 of Results:

Borgel D, Clauser S, Bornstain C, Bieche I, Bissery A, Remones V, Fagon JY, Aiach M, Diehl JL. Elevated growth-arrest-specific protein 6 plasma levels in patients with severe sepsis. Crit Care Med. 2006 Jan;34(1):219-22.

Publications automatically indexed to this study:

Borgel D, Bornstain C, Reitsma PH, Lerolle N, Gandrille S, Dali-Ali F, Esmon CT, Fagon JY, Aiach M, Diehl JL. A comparative study of the protein C pathway in septic and nonseptic patients with organ failure. Am J Respir Crit Care Med. 2007 Nov 1;176(9):878-85. Epub 2007 Aug 2.

Study ID Numbers:	PROCAS
Study First Received:	August 7, 2006
Last Updated:	August 9, 2006
ClinicalTrials.gov Identifier:	NCT00361725
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

severe sepsis
organ failure
activated protein C
thrombomodulin
EPCR

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Protein C
Inflammation

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009