A Phase 3 interventional study of Acetylsalicylic acid lysinate and 0.9% sodium-chloride solution in Critical Illness, sponsored by Medical University of Vienna. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Medical University of Vienna · Phase 3, Interventional, and Treatment
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.
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's enrollment of 15 is below the median of 90 across 1,003 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Exclusion Criteria:
100mg Acetylsalicylic Acid
Drug: Acetylsalicylic acid lysinate
0.9% sodium-chloride solution
Drug: 0.9% sodium-chloride solution
100mg intravenously administered Acetylsalicylic Acid lysinate per day
Placebo, intravenously administered, daily
28-day Mortality
Standard outcome measure of investigational intensive care unit trials.
Time frame: 28-days
Intensive Care Unit Mortality
Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer
Time frame: up to 90 days after inclusion
Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial
clinically relevant thromboembolic events assessed by standard care, potentially longer
Time frame: average 28 days
Bleeding Incidences
all bleeding incidence during the intensive care unit stay will be recorded. major bleeding criteria are taken from the Thrombolysis in myocardial infarction study (TIMI-Triton-38), potentially longer
Time frame: average 28days
| Milestone | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| Started | 7 | 8 |
| Completed | 6 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
Standard outcome measure of investigational intensive care unit trials.
| participants | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| 28-day Mortality | 1 | 1 |
Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer
| participants | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| Intensive Care Unit Mortality | 2 | 1 |
clinically relevant thromboembolic events assessed by standard care, potentially longer
| participants | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial | 0 | 1 |
all bleeding incidence during the intensive care unit stay will be recorded. major bleeding criteria are taken from the Thrombolysis in myocardial infarction study (TIMI-Triton-38), potentially longer
| counts | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| Bleeding Incidences | 1 | 0 |
Collected over Duration of the Trial: Inclusion until ICU discharge, up to 365 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acetylsalicylic Acid Lysinate | 2/7 (28.6%) | 2/7 (28.6%) | 4/7 (57.1%) |
| 0.9% Sodium-chloride Solution | 1/8 (12.5%) | 3/8 (37.5%) | 6/8 (75%) |
| Event | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| Aspiration PneumoniaRespiratory, thoracic and mediastinal disorders | 0/7 | 2/8 |
| AsystoliaCardiac disorders | 1/7 | 0/8 |
| Colon PerforationGastrointestinal disorders | 1/7 | 0/8 |
| Acute renal failureRenal and urinary disorders | 1/7 | 0/8 |
| hypoxic brain damageNervous system disorders | 0/7 | 1/8 |
| Catheter infectionProduct Issues | 0/7 | 1/8 |
| Event | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution |
|---|---|---|
| DeliriumNervous system disorders | 2/7 | 1/8 |
| PneumoniaInfections and infestations | 1/7 | 2/8 |
| BleedingVascular disorders | 1/7 | 0/8 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/7 | 0/8 |
| Liver function test increasedInvestigations | 1/7 | 0/8 |
| catheter infectionInfections and infestations | 1/7 | 0/8 |
| Wound infectionInfections and infestations | 1/7 | 0/8 |
| Herpes Virus InfectionInfections and infestations | 1/7 | 0/8 |
| atrial fibrillationCardiac disorders | 0/7 | 1/8 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/7 | 1/8 |
| Age, Categorical(Participants) | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 2 | 4 | 6 |
| Age, Continuous(years) | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution | Total |
|---|---|---|---|
| Median | 61 ± 15 | 63 ± 10 | 61 ± 12 |
| Sex: Female, Male(Participants) | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 4 | 6 | 10 |
| Race and Ethnicity Not Collected(Participants) | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution | Total |
|---|---|---|---|
| Austria | 7 | 8 | 15 |
| Simplified Acute Physiology Score III(score on a scale) | Acetylsalicylic Acid Lysinate | 0.9% Sodium-chloride Solution | Total |
|---|---|---|---|
| Median | 64 ± 19 | 63 ± 13 | 64 ± 15 |
Documents are hosted by the registry — open the source record to download them.
Ran from Nov 2011 to primary completion in Sep 2017, 69 months.
Results were first posted in Dec 2019, 2 years 3 months after primary completion.
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Studies of the drug tested here: Acetylsalicylic acid lysinate
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