Platelet Reactivity During Different Stages of Sepsis
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Sepsis Syndrome
- 发起方
- Charalambos .A. Gogos
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- P2Y12 mediated Platelet Reactivity on presentation
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
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.
研究者
Charalambos .A. Gogos
Professor in Internal Medicine and Infectious Diseases
University Hospital of Patras
入排标准
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
P2Y12 mediated Platelet Reactivity on presentation
时间窗: 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
时间窗: 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
次要结局
- Serum levels of pro-inflammatory mediators in various study groups(1 month to 1 year)
- Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups(1 month to 1 year)
- Repeated measurement of PRU in the same subject when transiting from one group to another(1 hour to 1 month)