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

NCT ID: NCT02062970

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

septic shock patients suffering

blood sample done in a population whom suffer of septic shock

Group Type: EXPERIMENTAL

blood draw

Intervention Type: BIOLOGICAL

Interventions

blood draw

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mondoloni Loic

Role: STUDY_DIRECTOR

Assistance Publique des Hôpitaux de Marseille

Locations

Assistance Publique des Hôpitaux de Marseille

Marseille, , France

Countries

France

References

Lacroix R, Judicone C, Souab KH, Bonifay A, Loundou A, Bouriche T, Cointe S, Vallier L, Abdili E, Arnaud L, Robert S, Poncelet P, Grosdidier C, Morange P, Cochery-Nouvellon E, Bouvier S, Gris JC, Lefrant JY, Leone M, Albanese J, Dignat-George F. The Procoagulant and Fibrinolytic Balance of Extracellular Vesicles Predicts Mortality in Septic Shock Patients. J Extracell Vesicles. 2025 Jun;14(6):e70073. doi: 10.1002/jev2.70073.

Reference Type: DERIVED

PMID: 40560804 (View on PubMed)

Other Identifiers

2013-36

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A01251-44

Identifier Type: -

Identifier Source: org_study_id