Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit

Medical University of Vienna

Status and phase: Terminated; Phase 3

Conditions: Critical Illness

Treatments: Drug: Acetylsalicylic acid lysinate; Drug: 0.9% sodium-chloride solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02285153

ASA-MORT

2012-002235-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Acetylsalicylic acid lysinate

Experimental group

Description:

100mg Acetylsalicylic Acid

Treatment:

Drug: Acetylsalicylic acid lysinate

0.9% sodium-chloride solution

Placebo Comparator group

Description:

0.9% sodium-chloride solution

Treatment:

Drug: 0.9% sodium-chloride solution