Platelet REactivity in Sepsis Syndrome (PRESS)

Completed

• Conditions: Sepsis Syndrome

• Registration Number: NCT02562261
• Lead Sponsor: Charalambos .A. Gogos

Brief Summary

Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the exact effects of bacterial products on platelet function have not been found to be consistent and may vary according to the species, the timing of the study, and the pathogenesis of sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation among patients with sepsis compared to healthy controls. Defining platelet's behaviour during sepsis is particularly important in view of recent findings revealing potential association between antiplatelet therapy and reduction in short term mortality, incidence of acute lung injury and intensive care unit admission in critically ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow up of patients going along different stages will also be performed. At the end of this study analysis of clinical and laboratory findings in correlation with platelet reactivity will be performed to assess platelet aggregation during sepsis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-26
• Study First Posted: 2015-09-29
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients presenting 0-8 hours post admission with signs of one of the following i) uncomplicated infection/bacteremia ii) sepsis iii) severe sepsis iv) septic shock
• 30 healthy subjects
• Signed informed consent

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Inability to give informed consent
• PLTs<70.000/ul or PLTs>741.000 ul
• Ht<25% or Ht>52%
• History of P2Y12 or GPIIb/IIIainhibitors the last 15 days prior assortment
• Patients with inherited (vonWillebrand factor deficiency, Glanzmann thrombasthenia, Bernard-Sulier syndrome) or established acquired platelet disorders (HIT)
• Patients undergoing hemodialysis
• History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
• Previous history of immunologic disease (neoplasm, autoimmune disorders, HIV)
• Subjects receiving daily treatment with immune-modulating regimens.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
P2Y12 mediated Platelet Reactivity on presentation	0 hours post presentation	Measurement of P2Y12 mediated platelet reactivity of patients in different study groups i.e healthy controls, uncomplicated infection, sepsis, severe sepsis/septic shock in P2Y12 reactivity units (PRU). PRU measurement will take place on time of presentation and recognition of signs of infection
Comparison of P2Y12 mediated Platelet Reactivity between study groups	at 1 year	Measurements of P2Y12 mediated platelet reactivity of different study groups that have taken place on presentation will be compared following completion of study recruitment

Secondary Outcome Measures

Name	Time	Method
Serum levels of pro-inflammatory mediators in various study groups	1 month to 1 year	Patient serum will be collected and cytokines will be measured in all patients
Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups	1 month to 1 year	Following measurement of serum cytokines (outcome 3), assessment of potential correlation with PRU will be performed
Repeated measurement of PRU in the same subject when transiting from one group to another	1 hour to 1 month	Patients transiting from one stage of sepsis to another (for example severe sepsis to healthy state OR from uncomplicated infection to sepsis) will be repetitively measured to assess platelet reactivity alteration

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patras, Achaia, Greece