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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 28-/90-day mortality [ Time Frame: 28-/90-days ]Standard outcome measure of investigational intensive care unit trials.
- 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
- inflammatory markers, [ Time Frame: up to 28 days ]routine-analysis, twice after inclusion, thereafter up to 28 days
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
|Contact: Bernd Jilma, Ao.Univ.Prof. Dr.||0043140400 ext email@example.com|
|Vienna, Austria, 1090|
|Contact: Bernd Jilma, Ao. Univ.-Prof. Dr. med 0140400 ext 2981 firstname.lastname@example.org|
|Principal Investigator: Bernd Jilma, Ao. Univ.-Prof. Dr. med|
|Principal Investigator:||Bernd Jilma, Ao. Univ.-Prof. Dr. med||Medical University of Vienna, Department of Clinical Pharmacology|