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Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock

Primary Purpose

the Coagulolytic Balance, the Mortality Rate, the Performance Used to Evaluate the Principal Objective Are Technical Performances, Sensibility and Specificity of the Tests

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood draw
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for the Coagulolytic Balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with septic shock

Exclusion Criteria:

  • age under 18 yo
  • pregnant woman
  • septic shock since more than 24 hours
  • patient hospitalized for cardiac arrest
  • immunocompromised patients
  • patient in whom the stop of active therapeutic is discuss
  • patient treated with an anti-coagulant at therapeutic dose

Sites / Locations

  • Assistance Publique des Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

septic shock patients suffering

Arm Description

blood sample done in a population whom suffer of septic shock

Outcomes

Primary Outcome Measures

Evaluate the interest of the measure of the coagulolytic balance, dependant of the circulating MP in the prognostic of mortality in a population of subjects presenting a septic shock.
The outcome of the study is to evaluate the interest of the measure of the coagulolytic balance, dependant of the circulating MP in the prognostic of mortality in a population of subjects presenting a septic shock. The objective is to evaluate the performance of this dosage while estimating the ROC-surve. In this present project: • the coagulolytic balance dependant of the MP is defined by the ratio between the activity of production of thrombin of circulating MP expressed by a speed in nM thrombin per minutes : and the activity of production of plasmin of circulating MP expressed by a speed in DD per minutes measured at inclusion of the subjects ; within 48 hours after diagnosis ;

Secondary Outcome Measures

Full Information

First Posted
November 28, 2013
Last Updated
May 28, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02062970
Brief Title
Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock
Official Title
Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV. Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response of the organism to a severe infection, associated with a circulatory failure marker by an arterial hypotension and a vascular hyperactivity to vasoconstrictor agents. The mechanisms involved on one hand an activation of white blood cells inflammatory system and the vascular inflammatory system; and on the other hand on imbalance in hemostatis characterized by an activation of the coagulation and an inappropriate fibrinolysis leading to a disruption of microcirculation in the context of a disseminated intravascular coagulation (DIVC). This inflammatory and thrombotic cellular activation is strongly associated with the phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by blood cells and vascular cells. MP are membranous vesicles, resulting in the reassortment of membrane phospholides in response to an activation of cellular apoptosis. They have been initially described as new actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF) confer them a procoagulating activity, which increases in patients undergoing septic shock. The finding of a fibriniolytic activity of the cellular MP suggests the existence of compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the control of the coagulolytic balance. Our recent researches suggest that endothelial and white blood cells MP produce in vivo plasmin. They carry into the main circulation a fibrinolytic activity which is partially beyond the physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that this ability of plasmin generation is important in patients affected with septic shock. Our hypothesis is that an increase in plasmin generation by MP compensates the risk of occurrence of microthrombosis, modulating therefore the vital prognosis of patients with septic shock. The coagulolytic balance of MP, which is resulting of their own procoagulating and fibrinolytic activities could claim the status of new pronostic marker relevant in patients with septic shock.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Coagulolytic Balance, the Mortality Rate, the Performance Used to Evaluate the Principal Objective Are Technical Performances, Sensibility and Specificity of the Tests

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
septic shock patients suffering
Arm Type
Experimental
Arm Description
blood sample done in a population whom suffer of septic shock
Intervention Type
Biological
Intervention Name(s)
blood draw
Primary Outcome Measure Information:
Title
Evaluate the interest of the measure of the coagulolytic balance, dependant of the circulating MP in the prognostic of mortality in a population of subjects presenting a septic shock.
Description
The outcome of the study is to evaluate the interest of the measure of the coagulolytic balance, dependant of the circulating MP in the prognostic of mortality in a population of subjects presenting a septic shock. The objective is to evaluate the performance of this dosage while estimating the ROC-surve. In this present project: • the coagulolytic balance dependant of the MP is defined by the ratio between the activity of production of thrombin of circulating MP expressed by a speed in nM thrombin per minutes : and the activity of production of plasmin of circulating MP expressed by a speed in DD per minutes measured at inclusion of the subjects ; within 48 hours after diagnosis ;
Time Frame
36 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with septic shock Exclusion Criteria: age under 18 yo pregnant woman septic shock since more than 24 hours patient hospitalized for cardiac arrest immunocompromised patients patient in whom the stop of active therapeutic is discuss patient treated with an anti-coagulant at therapeutic dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mondoloni Loic
Organizational Affiliation
Assistance Publique des Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique des Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock

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