Study of Platelet Activation in Septic Shock Patients (NCT02635854) | Clinical Trial Compass
CompletedNot Applicable
Study of Platelet Activation in Septic Shock Patients
France27 participantsStarted 2016-03
Plain-language summary
Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
EXPERIMENTAL GROUP
* Patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care
* Patients hospitalized in general intensive care
* Patient hospitalized for less than 72 hours
* Patient suffering from severe sepsis, whatever their origin, with hypotension (PAs \<90mmHg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock)
* Patient with a Sequential Organ Failure Assessment (SOFA) score\> 8 (or\> 2 in an organ) in the first 24 hours
* Patient enjoying a social security scheme or equivalent
CONTROL GROUP
* Signed informed consent
* Patient seen anesthesia consultation for orthopedic knee prosthesis of laying or hip with a negative balance infectious
* Patient enjoying a social security scheme or equivalent
Exclusion Criteria:
EXPERIMENTAL GROUP
* Patient on safeguarding justice, guardianship
* Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
* Patient suffering from thrombocytopenia or constitutional thrombopathy
* Pregnant
CONTROL GROUP
* Patient on safeguarding justice, guardianship
* Patient with infectious positive balance (dental, urinary tract) prior to surgery
* Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
* Patient suffering from thrombocytopenia or constitutional thrombopathy
* Pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)
Timeframe: T0 at the admission in intensive care unit
2
Level of platelets activation markers expression (CD62-P, CD63, CD42b)
Timeframe: T48 hours after admission in intensive care unit