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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
100mg intravenously administered Acetylsalicylic Acid lysinate per day
Placebo, intravenously administered, daily
General Hospital
Vienna, Austria
28-day Mortality
Standard outcome measure of investigational intensive care unit trials.
Time frame: 28-days
Intensive Care Unit Mortality
Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer
Time frame: up to 90 days after inclusion
Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial
clinically relevant thromboembolic events assessed by standard care, potentially longer
Time frame: average 28 days
Bleeding Incidences
all bleeding incidence during the intensive care unit stay will be recorded. major bleeding criteria are taken from the Thrombolysis in myocardial infarction study (TIMI-Triton-38), potentially longer
Time frame: average 28days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.