Study of Platelet Activation in Septic Shock Patients

Septic Shock Clinical Trial

— PASS  

Official title:

Study of Platelet Activation in Septic Shock Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635854
• Other study ID #: RC31/15/7738
• Secondary ID: 15 7738 02
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 5, 2017

Study information

• Verified date: August 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 5, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Review. — View Citation

Rahman M, Gustafsson D, Wang Y, Thorlacius H, Braun OÖ. 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of leukocyte-platelet aggregates		T0 at the admission in intensive care unit
Secondary	Kinetics of leukocyte-platelet aggregates formation		T0 at the admission in intensive care unit
Secondary	Correlation of leukocyte-platelet aggregates rate and septic shock severity.		T0 at the admission in intensive care unit
Secondary	Comparison of platelet activation in subjects treated or not with antiplatelet agents.		T0 at the admission in intensive care unit