Study of Platelet Activation in Septic Shock Patients (PASS)

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Other: Septic choc group; Other: Orthopedic surgery group

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Chu Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit.	Other: Septic 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.
Other: Control group; The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose.	Other: Orthopedic surgery group; Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood during the orthopedic surgical anesthesia consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)	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.	T0 at the admission in intensive care unit
Level of platelets activation markers expression (CD62-P, CD63, CD42b)	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.	T48 hours after admission in intensive care unit

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of leukocyte-platelet aggregates	T0 at the admission in intensive care unit
Kinetics of leukocyte-platelet aggregates formation	T0 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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Fanny BOUNES, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• Vardon-Bounes F, Garcia C, Piton A, Series J, Gratacap MP, Poette M, Seguin T, Crognier L, Ruiz S, Silva S, Conil JM, Minville V, Payrastre B. Evolution of platelet activation parameters during septic shock in intensive care unit. Platelets. 2022 Aug 18;33(6):918-925. doi: 10.1080/09537104.2021.2007873. Epub 2021 Dec 16.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 5, 2017

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimated): December 21, 2015

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: platelet activation; leukocyte and platelet aggregates
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: RC31/15/7738; 15 7738 02 (Other Grant/Funding Number: University Hospital Toulouse, local funding 2015)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO