medical patients admitted to an intensive care unit
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: over 18 years admittance to ICU ASA naive patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230
Exclusion criteria
Exclusion criteria: Known allergy or intolerance to ASA 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) recent ulcera recent gastrointestinal bleeding pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the 28-/90-day mortality of patients treated with ASA vs. placebo;;Secondary Objective: ICU-mortality of patients admitted treated with ASA or placebo; To examine whether ASA treatment reduces the incidence of thromboembolic events; pharmacokinetics and the pharmacodynamics of ASA in the intensive care unit; safety of ASA treatment assessed by post-mortem examinations (PME) with special regards to bleeding incidences; ;Primary end point(s): 28-/90-day mortality;Timepoint(s) of evaluation of this end point: end of ICU stay | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PD/PK thromboembolic events in ASA vs placebo group major bleeding ICU mortality post-mortem examination;Timepoint(s) of evaluation of this end point: 28/90 day mortality all other endpoints concern the duration of the icu stay | — |
Countries
Austria
Contacts
Medizinische Universität Wien - Universitätsklinik für klinische Pharmakologie