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

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ClinicalTrials.gov Identifier: NCT02285153
Recruitment Status : Recruiting
First Posted : November 6, 2014
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bernd Jilma, 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.


Condition or disease Intervention/treatment Phase
Critical Illness Drug: Acetylsalicylic acid lysinate Drug: 0.9% sodium-chloride solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
Study Start Date : November 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetylsalicylic acid lysinate
100mg Acetylsalicylic Acid
Drug: Acetylsalicylic acid lysinate
100mg intravenously administered Acetylsalicylic Acid lysinate per day

Placebo Comparator: 0.9% sodium-chloride solution
0.9% sodium-chloride solution
Drug: 0.9% sodium-chloride solution
Placebo, intravenously administered, daily




Primary Outcome Measures :
  1. 28-/90-day mortality [ Time Frame: 28-/90-days ]
    Standard outcome measure of investigational intensive care unit trials.


Secondary Outcome Measures :
  1. intensive care unit mortality [ Time Frame: up to 90 days after inclusion ]
    Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer

  2. plasma levels of specific medications and platelet function as described [ Time Frame: day 1 and day 6-8 ]
    Serum thromboxane B2 levels 6-keto-PGF1-alpha (Prostaglandin) levels acetylsalicylic acid/Salicylate serum concentrations AUC (Area under the curve) MEA (Multiplate electrode analyzer): arachidonic acid induced aggregation Closure time (s) (PFA-100) CEPI-CT (closure time with epinephrine as stimulus), CADP-CT (closure time with ADP as stimulus), or Innovance CT (closure time assessed by innovance)

  3. Incidence of thromboembolic events [ Time Frame: average 28 days ]
    clinically relevant thromboembolic events assessed by standard care, potentially longer

  4. post-mortem-examinations [ Time Frame: average 28 days ]
    post mortem examinations will be carried out in all patients who die during their intensive care unit stay. specific interest will be paid to thromboembolic events, potentially longer

  5. bleeding incidences [ Time Frame: average 28days ]
    all bleeding incidence during the intensive care unit stay will be recorded. major bleeding criteria are taken from the TIMI-Triton-38 study (Thrombolysis in myocardial infarction), potentially longer


Other Outcome Measures:
  1. inflammatory markers, [ Time Frame: up to 28 days ]
    routine-analysis, twice after inclusion, thereafter up to 28 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285153


Contacts
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Contact: Bernd Jilma, Ao.Univ.Prof. Dr. 0043140400 ext 2981 bernd.jilma@meduniwien.ac.at

Locations
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Austria
General Hospital Recruiting
Vienna, Austria, 1090
Contact: Bernd Jilma, Ao. Univ.-Prof. Dr. med    0140400 ext 2981    bernd.jilma@meduniwien.ac.at   
Principal Investigator: Bernd Jilma, Ao. Univ.-Prof. Dr. med         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Bernd Jilma, Ao. Univ.-Prof. Dr. med Medical University of Vienna, Department of Clinical Pharmacology

Publications:
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Responsible Party: Bernd Jilma, Ao. Univ.-Prof. Dr. Bernd Jilma, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02285153     History of Changes
Other Study ID Numbers: ASA-MORT
2012-002235-29 ( EudraCT Number )
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by Bernd Jilma, Medical University of Vienna:
acetylsalicylic acid
intensive care unit
mortality
Post mortem examination
bleeding

Additional relevant MeSH terms:
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Aspirin
Acetylsalicylic acid lysinate
Critical Illness
Disease Attributes
Pathologic Processes
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics