跳至主要内容
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 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
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)

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

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
  • •Patient enjoying a social security scheme or equivalent

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

研究组 & 干预措施

Test group

Experimental

The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit.

干预措施: Septic choc group (Other)

Control group

Other

The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose.

干预措施: Orthopedic surgery group (Other)

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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