Critical Illness Clinical Trial
Official title:
Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
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.
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