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Does acetylsalicylic acid reduce the mortality of patients admitted to an Intensive Care Unit

Does acetylsalicylic acid reduce the mortality of patients admitted to an Intensive Care Unit - ASA-MORT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002235-29-AT
Enrollment
Unknown
Registered
2012-10-01
Start date
2012-10-23
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

medical patients admitted to an intensive care unit

Interventions

Trade Name: Aspirin i.v. 500mg Product Name: Aspirin i.v. 500mg Product Code: Aspirin i.v. 500mg Pharmaceutical Form: Powder and solvent for solution for infusion CAS Number: 50-78-2 Other descriptive

Sponsors

Medizinische Universität Wien - Universitätsklinik für klinische Pharmakologie
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactMedizinische Universität Wien - Uni

Medizinische Universität Wien - Universitätsklinik für klinische Pharmakologie

klin-pharmakologie@meduniwien.ac.at004301404002980

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026