Platelet REactivity in Sepsis Syndrome (PRESS)
This trial is active, not recruiting.
|Sponsor||Charalambos .A. Gogos|
|Collaborator||Hellenic Society for Chemotherapy : Hellenic Sepsis Study Group|
|Start date||January 2015|
|End date||December 2016|
|Trial size||140 participants|
|Trial identifier||NCT02562261, 24958/19-12-13|
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.
P2Y12 mediated Platelet Reactivity on presentation
time frame: 0 hours post presentation
Comparison of P2Y12 mediated Platelet Reactivity between study groups
time frame: at 1 year
Serum levels of pro-inflammatory mediators in various study groups
time frame: 1 month to 1 year
Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups
time frame: 1 month to 1 year
Repeated measurement of PRU in the same subject when transiting from one group to another
time frame: 1 hour to 1 month
Male or female participants from 18 years up to 85 years old.
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.
|Official title||Platelet Reactivity During Different Stages of Sepsis|
|Principal investigator||Karolina Akinosoglou, MD,PhD|
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