Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
Condition: Critical Illness
MeSH terms: Critical Illness
Intervention: Acetylsalicylic acid lysinate; 0.9% sodium-chloride solution
Intervention description: 100mg intravenously administered Acetylsalicylic Acid lysinate per day; Placebo, intravenously administered, daily
Intervention MeSH terms: Aspirin; Acetylsalicylic acid lysinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acetylsalicylic acid; intensive care unit; mortality; Post mortem examination; bleeding

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients admitted to an intensive care unit

          -  >18 years of age

        Exclusion Criteria:

          -  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