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

Phase 3

Terminated

• Conditions: Critical Illness
• Interventions: Drug: 0.9% sodium-chloride solution; Drug: Acetylsalicylic acid lysinate

• Registration Number: NCT02285153
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-15
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Primary Completion: 2017-09-05
• Study Completion: 2017-11-10
• Results First Submitted: 2019-08-18
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-28
• Last Update Submitted: 2019-11-28
• Results First Posted: 2019-12-18
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• patients admitted to an intensive care unit
• >18 years of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% sodium-chloride solution	0.9% sodium-chloride solution	0.9% sodium-chloride solution
Acetylsalicylic acid lysinate	Acetylsalicylic acid lysinate	100mg Acetylsalicylic Acid

Primary Outcome Measures

Name	Time	Method
28-day Mortality	28-days	Standard outcome measure of investigational intensive care unit trials.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial	average 28 days	clinically relevant thromboembolic events assessed by standard care, potentially longer
Intensive Care Unit Mortality	up to 90 days after inclusion	Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer
Bleeding Incidences	average 28days	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

Trial Locations

Locations (1)

General Hospital; 🇦🇹 Vienna, Austria