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临床试验/NCT02285153
NCT02285153终止3 期

Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2011年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
15
试验地点
1
主要终点
28-day Mortality

研究概览

简要总结

Platelets play a central part not just in homeostasis and thrombosis as the primary effector cells, but they are also key cells in the regulation of the immunological response to various stressors. After activation, platelets release their granules which store different inflammatory mediators that induce coagulation, recruit further platelets, activate complement, attract neutrophils and leukocytes and regulate the vascular tone. Platelets activated by systemic inflammation and infection, may also contribute to the development of multiple organ failure. Thus, inhibition of platelet activation may have beneficial effects on critically ill patients.

the investigators hypothesize that acetylsalicylic acid reduces the mortality of medical intensive care unit patients. In a retrospective study acetylsalicylic acid use was associated with a substantial reduction in a medical intensive care unit population (Winning et al., 2010).

The investigators will conduct a randomized, double-blind study including 460 patients (2x230), who will be randomized to receive 100mg acetylsalicylic acid(daily, intravenous) or a placebo (0,9% sodium-choride solution) to assess whether acetylsalicylic acid reduces the mortality of medical intensive care unit patients.

Main outcome criteria will be 28/90day-mortality. Furthermore the investigators will assess whether acetylsalicylic acid reduces the risk of suffering thromboembolic complications.

Post-mortem examinations will be conducted in all patients who die in the course of the study.

Furthermore we will assess bleeding rates, intensive care unit mortality and pharmacokinetic and pharmacodynamic properties of acetylsalicylic acid in the intensive care unit population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double blind

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

  • patients admitted to an intensive care unit
  • >18 years of age

排除标准

  • known allergy of intolerance to acetylsalicylic acid
  • recent surgery or planned surgery
  • active bleeding
  • known coagulation disorders
  • discretion of the physician
  • terminal illness (anticipated life expectancy <3months; e.g. due to cancer)
  • platelet count <20 000
  • recent ulcera
  • recent gastrointestinal bleeding
  • pregnancy

研究组 & 干预措施

0.9% sodium-chloride solution

Placebo Comparator

0.9% sodium-chloride solution

干预措施: 0.9% sodium-chloride solution (Drug)

Acetylsalicylic acid lysinate

Experimental

100mg Acetylsalicylic Acid

干预措施: Acetylsalicylic acid lysinate (Drug)

结局指标

主要结局

28-day Mortality

时间窗: 28-days

Standard outcome measure of investigational intensive care unit trials.

次要结局

  • Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial(average 28 days)
  • Intensive Care Unit Mortality(up to 90 days after inclusion)
  • Bleeding Incidences(average 28days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernd Jilma

Ao. Univ.-Prof. Dr. Bernd Jilma

Medical University of Vienna

研究点 (1)

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