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

NCT ID: NCT02285153

Last Updated: 2019-12-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-15
• Study Completion Date: 2017-11-10

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.

Conditions

Critical Illness

Keywords

acetylsalicylic acid; intensive care unit; mortality; Post mortem examination; bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acetylsalicylic acid lysinate

100mg Acetylsalicylic Acid

Group Type: EXPERIMENTAL

Acetylsalicylic acid lysinate

Intervention Type: DRUG

100mg intravenously administered Acetylsalicylic Acid lysinate per day

0.9% sodium-chloride solution

0.9% sodium-chloride solution

Group Type: PLACEBO_COMPARATOR

0.9% sodium-chloride solution

Intervention Type: DRUG

Placebo, intravenously administered, daily

Interventions

Acetylsalicylic acid lysinate

100mg intravenously administered Acetylsalicylic Acid lysinate per day

Intervention Type: DRUG

0.9% sodium-chloride solution

Placebo, intravenously administered, daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Bernd Jilma

Ao. Univ.-Prof. Dr. Bernd Jilma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernd Jilma, Ao. Univ.-Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Clinical Pharmacology

Locations

General Hospital

Vienna, , Austria

Countries

Austria

References

Winning J, Neumann J, Kohl M, Claus RA, Reinhart K, Bauer M, Losche 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.

Reference Type: BACKGROUND

PMID: 19770746 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2012-002235-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ASA-MORT

Identifier Type: -

Identifier Source: org_study_id