Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
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
- 否
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
0.9% sodium-chloride solution
干预措施: 0.9% sodium-chloride solution (Drug)
Acetylsalicylic acid lysinate
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
Bernd Jilma
Ao. Univ.-Prof. Dr. Bernd Jilma
Medical University of Vienna
