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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002235-29 | EudraCT Number |
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Recruitment of planned number of Subjects was not feasible.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylic acid lysinate | Experimental | 100mg Acetylsalicylic Acid |
|
| 0.9% sodium-chloride solution | Placebo Comparator | 0.9% sodium-chloride solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid lysinate | Drug | 100mg intravenously administered Acetylsalicylic Acid lysinate per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day Mortality | Standard outcome measure of investigational intensive care unit trials. | 28-days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit Mortality | Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer | up to 90 days after inclusion |
| Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Jilma, Ao. Univ.-Prof. Dr. med | Medical University of Vienna, Department of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19770746 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetylsalicylic Acid Lysinate | 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day |
| FG001 | 0.9% Sodium-chloride Solution | 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetylsalicylic Acid Lysinate | 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day |
| BG001 | 0.9% Sodium-chloride Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 28-day Mortality | Standard outcome measure of investigational intensive care unit trials. | modified Intention to treat population (all patients who received at least a single dose of acetylsalicylic acid) | Posted | Number | participants | 28-days |
|
Duration of the Trial: Inclusion until ICU discharge, up to 365 days
mortality was the primary endpoint. Therefore death was treated as an endpoint rather than a serious adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetylsalicylic Acid Lysinate | 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asystolia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Vascular disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernd Jilma | Medical University of Vienna | +434040029180 | bernd.jilma@meduniwien.ac.at |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2012 | Aug 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C010395 | acetylsalicylic acid lysinate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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double blind
| 0.9% sodium-chloride solution | Drug | Placebo, intravenously administered, daily |
|
clinically relevant thromboembolic events assessed by standard care, potentially longer
| 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 | average 28days |
0.9% sodium-chloride solution
0.9% sodium-chloride solution: Placebo, intravenously administered, daily
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Simplified Acute Physiology Score III | The Simplified Acute Physiology Score III is a commonly used disease severity score specifically designed for critically ill patients. It was calculated on the day of admission The score may range from 0 to 217 points. The score includes information on conditions that led to ICU admission, underlying diseases, ventilation, catecholamine use, laboratory data Higher scores predicted mortality, while lower scores were associated with survival. | Median | Standard Deviation | score on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
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| Secondary | Intensive Care Unit Mortality | Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer | Posted | Number | participants | up to 90 days after inclusion |
|
|
|
|
| Secondary | Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial | clinically relevant thromboembolic events assessed by standard care, potentially longer | Posted | Number | participants | average 28 days |
|
|
|
|
| Secondary | 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 | Posted | Number | counts | average 28days |
|
|
|
|
| 2 |
| 7 |
| 2 |
| 7 |
| 4 |
| 7 |
| EG001 | 0.9% Sodium-chloride Solution | 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily | 1 | 8 | 3 | 8 | 6 | 8 |
| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hypoxic brain damage | Nervous system disorders | Non-systematic Assessment |
|
| Colon Perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Catheter infection | Product Issues | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Delirium | Nervous system disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Obstipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Liver function test increased | Investigations | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| catheter infection | Infections and infestations | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes Virus Infection | Infections and infestations | Non-systematic Assessment |
|
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| D017670 |
| Sodium Compounds |