the Coagulolytic BalanceNCT02062970
Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock
A study testing blood draw in people with the Coagulolytic Balance and the Mortality Rate, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Coagulolytic Balance, the Mortality Rate, the Performance Used to Evaluate the Principal Objective Are Technical Performances, Sensibility and Specificity of the Tests
- What is being tested?
- blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with septic shock
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawBiological
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients suffering | Experimental | blood sample done in a population whom suffer of septic shock Receives: Biological: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ;
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2018
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for the Coagulolytic BalanceStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mondoloni Loic, Study director, Assistance Publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062970
- Sponsor's protocol ID
- 2013-A01251-44
- Other IDs
- 2013-36
- Status last verified
- May 2019
- First submitted
- 28 Nov 2013
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40560804
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock
- ClinicalTrials.gov ID
- NCT02062970
- Acronym / sponsor ID
- 2013-A01251-44
- 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 type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septic shock patients suffering | Experimental | Biological: blood drawblood sample done in a population whom suffer of septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with septic shock
Key exclusion criteria (7 listed)
- age under 18 yo
- pregnant woman
- septic shock since more than 24 hours
- patient hospitalized for cardiac arrest
- immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw | Biological | septic shock patients suffering |
Primary outcome
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.
Time frame: 36 month
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 ;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Derived from this study: PubMed 40560804Lacroix 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.
Related trials for the Coagulolytic Balance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mondoloni Loic study director
Assistance Publique des Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood draw in people with the Coagulolytic Balance and the Mortality Rate, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.