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Study of Platelet Activation in Septic Shock Patients (PASS)

Primary Purpose

Septic Shock

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Septic choc group

Orthopedic surgery group

About this trial

This is an interventional basic science trial for Septic Shock focused on measuring leukocyte and platelet aggregates, platelet activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test group

Control group

Arm Description

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

The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Rate of leukocyte-platelet aggregates

Kinetics of leukocyte-platelet aggregates formation

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

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

Full Information

NCT ID

NCT02635854

First Posted

December 14, 2015

Last Updated

August 13, 2018

Sponsor

University Hospital, Toulouse

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02635854

Brief Title

Study of Platelet Activation in Septic Shock Patients

Acronym

PASS

Official Title

Study of Platelet Activation in Septic Shock Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

leukocyte and platelet aggregates, platelet activation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Other

Arm Description

The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose.

Intervention Type

Other

Intervention Name(s)

Septic choc group

Intervention Description

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

Intervention Name(s)

Orthopedic surgery group

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

T0 at the admission in intensive care unit

Title

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

Description

Time Frame

T48 hours after admission in intensive care unit

Secondary Outcome Measure Information:

Title

Rate of leukocyte-platelet aggregates

Time Frame

T0 at the admission in intensive care unit

Title

Kinetics of leukocyte-platelet aggregates formation

Time Frame

T0 at the admission in intensive care unit

Title

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

Time Frame

T0 at the admission in intensive care unit

Title

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

Time Frame

T0 at the admission in intensive care unit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fanny BOUNES, MD

Organizational Affiliation

CHU Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Toulouse

City

Toulouse

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23509620

Citation

Valerio-Rojas JC, Jaffer IJ, Kor DJ, Gajic O, Cartin-Ceba R. Outcomes of severe sepsis and septic shock patients on chronic antiplatelet treatment: a historical cohort study. Crit Care Res Pract. 2013;2013:782573. doi: 10.1155/2013/782573. Epub 2013 Feb 20.

Results Reference

background

PubMed Identifier

23855479

Citation

Rahman M, Gustafsson D, Wang Y, Thorlacius H, Braun OO. Ticagrelor reduces neutrophil recruitment and lung damage in abdominal sepsis. Platelets. 2014;25(4):257-63. doi: 10.3109/09537104.2013.809520. Epub 2013 Jul 15.

Results Reference

background

PubMed Identifier

21075430

Citation

Li Z, Yang F, Dunn S, Gross AK, Smyth SS. Platelets as immune mediators: their role in host defense responses and sepsis. Thromb Res. 2011 Mar;127(3):184-8. doi: 10.1016/j.thromres.2010.10.010. Epub 2010 Nov 13.

Results Reference

background

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Study of Platelet Activation in Septic Shock Patients

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