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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

Tracking Information
First Submitted Date  ICMJE October 24, 2012
First Posted Date  ICMJE November 6, 2014
Last Update Posted Date March 24, 2017
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
28-/90-day mortality [ Time Frame: 28-/90-days ]
Standard outcome measure of investigational intensive care unit trials.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02285153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
  • 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
  • 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)
  • Incidence of thromboembolic events [ Time Frame: average 28 days ]
    clinically relevant thromboembolic events assessed by standard care, potentially longer
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 4, 2014)
inflammatory markers, [ Time Frame: up to 28 days ]
routine-analysis, twice after inclusion, thereafter up to 28 days
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
Official Title  ICMJE Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Critical Illness
Intervention  ICMJE
  • Drug: Acetylsalicylic acid lysinate
    100mg intravenously administered Acetylsalicylic Acid lysinate per day
  • Drug: 0.9% sodium-chloride solution
    Placebo, intravenously administered, daily
Study Arms  ICMJE
  • Experimental: Acetylsalicylic acid lysinate
    100mg Acetylsalicylic Acid
    Intervention: Drug: Acetylsalicylic acid lysinate
  • Placebo Comparator: 0.9% sodium-chloride solution
    0.9% sodium-chloride solution
    Intervention: Drug: 0.9% sodium-chloride solution
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2014)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bernd Jilma, Ao.Univ.Prof. Dr. 0043140400 ext 2981 bernd.jilma@meduniwien.ac.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02285153
Other Study ID Numbers  ICMJE ASA-MORT
2012-002235-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernd Jilma, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernd Jilma, Ao. Univ.-Prof. Dr. med Medical University of Vienna, Department of Clinical Pharmacology
PRS Account Medical University of Vienna
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP