Study of Platelet Activation in Septic Shock Patients

NCT ID: NCT02635854

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test group

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

Group Type EXPERIMENTAL

Septic choc group

Intervention Type 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.

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.

Group Type OTHER

Orthopedic surgery group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fanny BOUNES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34915822 (View on PubMed)

Other Identifiers

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15 7738 02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC31/15/7738

Identifier Type: -

Identifier Source: org_study_id

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