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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00361725
Other study ID # PROCAS
Secondary ID
Status Terminated
Phase N/A
First received August 7, 2006
Last updated August 9, 2006
Start date March 2003
Est. completion date October 2003

Study information

Verified date June 2006
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 90
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (1)

Borgel D, Clauser S, Bornstain C, Bièche 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. — View Citation

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