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Status unknownNCT02062970Updated May 30, 2019

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

An interventional study of blood draw in the Coagulolytic Balance, the Mortality Rate and the Performance Used to Evaluate the Principal Objective Are Technical Performances, Sensibility and Specificity of the Tests, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's enrollment of 230 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with septic shock

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    septic shock patients suffering

    blood sample done in a population whom suffer of septic shock

    Biological: blood draw

Interventions

  • Biologicalblood draw
06

What researchers measure

Primary outcomes

  1. 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 ;

    Time frame: 36 month

07

Study locations

1 site
  • Assistance Publique des Hôpitaux de Marseille
    Marseille, 13000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02062970
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Feb 14, 2014
Start date
Feb 2014
Primary completion
Jan 2018
Completion
Sep 2019 (estimated)
Last update
May 30, 2019

Study contacts

Mondoloni Loic
study director · Assistance Publique des Hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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