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临床试验/NCT02562261
NCT02562261
已完成
不适用

Platelet Reactivity During Different Stages of Sepsis

Charalambos .A. Gogos1 个研究点 分布在 1 个国家目标入组 140 人2015年1月

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.

注册库
clinicaltrials.gov
开始日期
2015年1月
结束日期
2016年6月
最后更新
7年前
研究类型
Observational
性别
All

研究者

发起方
Charalambos .A. Gogos
责任方
Sponsor Investigator
主要研究者

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)

研究点 (1)

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