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临床试验/NCT02635854
NCT02635854
已完成
不适用

Study of Platelet Activation in Septic Shock Patients

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 27 人2016年3月1日
适应症Septic Shock

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Septic Shock
发起方
University Hospital, Toulouse
入组人数
27
试验地点
1
主要终点
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)
状态
已完成
最后更新
4个月前

概览

简要总结

Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.

注册库
clinicaltrials.gov
开始日期
2016年3月1日
结束日期
2017年1月5日
最后更新
4个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • EXPERIMENTAL GROUP
  • Patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care
  • Patients hospitalized in general intensive care
  • Patient hospitalized for less than 72 hours
  • Patient suffering from severe sepsis, whatever their origin, with hypotension (PAs \<90mmHg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock)
  • Patient with a Sequential Organ Failure Assessment (SOFA) score\> 8 (or\> 2 in an organ) in the first 24 hours
  • Patient enjoying a social security scheme or equivalent
  • CONTROL GROUP
  • Signed informed consent
  • Patient seen anesthesia consultation for orthopedic knee prosthesis of laying or hip with a negative balance infectious

排除标准

  • EXPERIMENTAL GROUP
  • Patient on safeguarding justice, guardianship
  • Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
  • Patient suffering from thrombocytopenia or constitutional thrombopathy
  • CONTROL GROUP
  • Patient on safeguarding justice, guardianship
  • Patient with infectious positive balance (dental, urinary tract) prior to surgery
  • Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
  • Patient suffering from thrombocytopenia or constitutional thrombopathy

结局指标

主要结局

Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)

时间窗: T0 at the admission in intensive care unit

Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit for patients in test group and during the orthopedic surgical anesthesia consultation for patients in control group.

Level of platelets activation markers expression (CD62-P, CD63, CD42b)

时间窗: T48 hours after admission in intensive care unit

Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood 48 hours later admission in intensive care unit only for patients in test group.

次要结局

  • Correlation of leukocyte-platelet aggregates rate and septic shock severity.(T0 at the admission in intensive care unit)
  • Comparison of platelet activation in subjects treated or not with antiplatelet agents.(T0 at the admission in intensive care unit)
  • Rate of leukocyte-platelet aggregates(T0 at the admission in intensive care unit)
  • Kinetics of leukocyte-platelet aggregates formation(T0 at the admission in intensive care unit)

研究点 (1)

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