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Study of Platelet Activation in Septic Shock Patients

Study of Platelet Activation in Septic Shock Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02635854
Acronym
PASS
Enrollment
27
Registered
2015-12-21
Start date
2016-03-31
Completion date
2017-01-05
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

leukocyte and platelet aggregates, platelet activation

Brief 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.

Interventions

OTHERSeptic choc group

Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit and 48 hours later for leukocyte-platelet aggregates measurements.

OTHEROrthopedic surgery group

Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood during the orthopedic surgical anesthesia consultation.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)T0 at the admission in intensive care unitSpecific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit for patients in test group and during the orthopedic surgical anesthesia consultation for patients in control group.
Level of platelets activation markers expression (CD62-P, CD63, CD42b)T48 hours after admission in intensive care unitSpecific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood 48 hours later admission in intensive care unit only for patients in test group.

Secondary

MeasureTime frame
Rate of leukocyte-platelet aggregatesT0 at the admission in intensive care unit
Kinetics of leukocyte-platelet aggregates formationT0 at the admission in intensive care unit
Correlation of leukocyte-platelet aggregates rate and septic shock severity.T0 at the admission in intensive care unit
Comparison of platelet activation in subjects treated or not with antiplatelet agents.T0 at the admission in intensive care unit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026