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Completed

NCT Number: NCT02635854

Study of Platelet Activation in Septic Shock Patients

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Septic choc group

Other

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.

Orthopedic surgery group

Other

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

Primary outcomes

  1. Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)

    Time frame: T0 at the admission in intensive care unit

    Specific 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.

  2. Level of platelets activation markers expression (CD62-P, CD63, CD42b)

    Time frame: T48 hours after admission in intensive care unit

    Specific 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 outcomes

  1. Rate of leukocyte-platelet aggregates

    Time frame: T0 at the admission in intensive care unit

  2. Kinetics of leukocyte-platelet aggregates formation

    Time frame: T0 at the admission in intensive care unit

  3. Correlation of leukocyte-platelet aggregates rate and septic shock severity.

    Time frame: T0 at the admission in intensive care unit

  4. Comparison of platelet activation in subjects treated or not with antiplatelet agents.

    Time frame: T0 at the admission in intensive care unit

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: PASS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2015
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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