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

NCT02285153 | Terminated Phase 3 Results DMC

• 2 other identifiers: ASA-MORT2012-002235-29
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 28-day Mortality

  Standard outcome measure of investigational intensive care unit trials.

  28-days

Secondary Outcomes (3)

• Intensive Care Unit Mortality

  up to 90 days after inclusion

• Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial

  average 28 days

• Bleeding Incidences

  average 28days

Study Arms (2)

Acetylsalicylic acid lysinate

EXPERIMENTAL

100mg Acetylsalicylic Acid

Drug: Acetylsalicylic acid lysinate

0.9% sodium-chloride solution

PLACEBO COMPARATOR

0.9% sodium-chloride solution

Drug: 0.9% sodium-chloride solution

Interventions

Acetylsalicylic acid lysinate DRUG

100mg intravenously administered Acetylsalicylic Acid lysinate per day

Acetylsalicylic acid lysinate

0.9% sodium-chloride solution DRUG

Placebo, intravenously administered, daily

0.9% sodium-chloride solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

General Hospital

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 19770746 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Hemorrhage

Interventions

acetylsalicylic acid lysinate; Sodium Chloride

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The study had to be terminated because of a poor recruitment rate. Thus, all results need to be interpreted with great caution. Patients were critically ill. Hence, the occurrence of adverse events should be interpreted accordingly.

Results Point of Contact

• Title: Bernd Jilma
• Organization: Medical University of Vienna

bernd.jilma@meduniwien.ac.at

+434040029180

Study Officials

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

  Medical University of Vienna, Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao. Univ.-Prof. Dr. Bernd Jilma

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 6, 2014
• Study Start: November 15, 2011
• Primary Completion: September 5, 2017
• Study Completion: November 10, 2017
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-11

Locations

AU (1)