Study of Platelet Activation in Septic Shock Patients

NCT02635854 | Completed

• 2 other identifiers: RC31/15/773815 7738 02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

leukocyte and platelet aggregates; platelet activation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Test group

EXPERIMENTAL

The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit.

Other: Septic choc group

Control group

OTHER

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

Interventions

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.

Test group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EXPERIMENTAL GROUP
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 34915822 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Fanny BOUNES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 21, 2015
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 5, 2017
• Last Updated: December 10, 2025

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)