跳至主要内容
临床试验/NCT03716310
NCT03716310已完成不适用

Impaired Platelet Reactivity as an Early Biomarker for Sepsis-related Thrombocytopenia

Università degli Studi di Ferrara1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Occurence of sepsis-induced thrombocytopenia

研究概览

简要总结

Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of septic shock
  • platelet count >150*103/mcL.

排除标准

  • age <18 years
  • history of any hematologic disorder
  • chronic liver failure
  • previous chemotherapy
  • transfusion of platelet during the previous 4 weeks
  • renal replacement therapy before ICU admission
  • history of antiplatelet therapy during the 8 days before inclusion
  • history of heparin-induced thrombocytopenia (HIT) or other acquired or induced thrombocytopenia
  • occurrence of HIT (defined as HIT score over 3)
  • active bleeding

结局指标

主要结局

Occurence of sepsis-induced thrombocytopenia

时间窗: 5 days after study inclusion

Occurence of platelet count \<150 \*103/μL

次要结局

  • number of Red blood cells (RBC) packs transfused during ICU stay(After 28 days from study inclusion)
  • life-threatening bleeding(After 28 days from study inclusion)
  • 90-day mortality(after 90 days from study enrollment)

研究者

发起方
Università degli Studi di Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Fogagnolo

MD

Università degli Studi di Ferrara

研究点 (1)

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