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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02285153
• Other study ID #: ASA-MORT
• Secondary ID: 2012-002235-29
• Status: Terminated
• Phase: Phase 3
• Start date: November 15, 2011
• Est. completion date: November 10, 2017

Study information

• Verified date: November 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 10, 2017
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Acetylsalicylic acid lysinate
100mg intravenously administered Acetylsalicylic Acid lysinate per day
• 0.9% sodium-chloride solution
Placebo, intravenously administered, daily

Locations

Country	Name	City	State
Austria	General Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Winning J, Neumann J, Kohl M, Claus RA, Reinhart K, Bauer M, Lösche W. Antiplatelet drugs and outcome in mixed admissions to an intensive care unit. Crit Care Med. 2010 Jan;38(1):32-7. doi: 10.1097/CCM.0b013e3181b4275c. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day Mortality	Standard outcome measure of investigational intensive care unit trials.	28-days
Secondary	Intensive Care Unit Mortality	Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer	up to 90 days after inclusion
Secondary	Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial	clinically relevant thromboembolic events assessed by standard care, potentially longer	average 28 days
Secondary	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	average 28days