Critical IllnessPhase 3NCT02285153
Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
A Phase 3 study testing Acetylsalicylic acid lysinate and 0.9% sodium-chloride solution in people with Critical Illness, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Acetylsalicylic acid lysinate and 0.9% sodium-chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 15 Nov 2011to 10 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to an intensive care unit
- >18 years of age
Who cannot join
- 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)
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- platelet count <20 000
- recent ulcera
- recent gastrointestinal bleeding
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Critical Illness
- Being tested
- Acetylsalicylic acid lysinate, 0.9% sodium-chloride solution
- Keywords
- acetylsalicylic acid, intensive care unit, mortality, Post mortem examination, bleeding
- Medical subject headings
- Critical Illness, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid lysinateDrug
100mg intravenously administered Acetylsalicylic Acid lysinate per day
0.9% sodium-chloride solutionDrug
Placebo, intravenously administered, daily
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic acid lysinate | Experimental | 100mg Acetylsalicylic Acid Receives: Drug: Acetylsalicylic acid lysinate |
| 0.9% sodium-chloride solution | Placebo comparator | 0.9% sodium-chloride solution Receives: Drug: 0.9% sodium-chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality
Standard outcome measure of investigational intensive care unit trials.
Measured: 28-days
Secondary outcomes (3)
Intensive Care Unit Mortality
Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer
Measured: 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
Measured: 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
Measured: average 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start15 Nov 2011
- Primary completion5 Sep 2017
- Study completion10 Nov 2017
Why it stopped: Recruitment of planned number of Subjects was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernd Jilma, Medical University of Vienna
- Investigators
- Bernd Jilma, Ao. Univ.-Prof. Dr. med, Principal investigator, Medical University of Vienna, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285153
- Sponsor's protocol ID
- ASA-MORT
- Other IDs
- 2012-002235-29
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2012
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19770746
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02285153
- Acronym / sponsor ID
- ASA-MORT
- Conditions
- Critical Illness
- Keywords
- acetylsalicylic acid, intensive care unit, mortality, Post mortem examination, bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment of planned number of Subjects was not feasible.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Nov 2011 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic acid lysinate | Experimental | Drug: Acetylsalicylic acid lysinate100mg Acetylsalicylic Acid |
| 0.9% sodium-chloride solution | Placebo comparator | Drug: 0.9% sodium-chloride solution0.9% sodium-chloride solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients admitted to an intensive care unit
- >18 years of age
Key exclusion criteria (10 listed)
- known allergy of intolerance to acetylsalicylic acid
- recent surgery or planned surgery
- active bleeding
- known coagulation disorders
- discretion of the physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid lysinate100mg intravenously administered Acetylsalicylic Acid lysinate per day | Drug | Acetylsalicylic acid lysinate |
| 0.9% sodium-chloride solutionPlacebo, intravenously administered, daily | Drug | 0.9% sodium-chloride solution |
Primary outcome
28-day Mortality
Time frame: 28-days
Standard outcome measure of investigational intensive care unit trials.
3 secondary outcomes
Intensive Care Unit Mortality
Time frame: up to 90 days after inclusion
Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial
Time frame: average 28 days
Bleeding Incidences
Time frame: average 28days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19770746Winning 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Jilma, Ao. Univ.-Prof. Dr. med principal investigator
Medical University of Vienna, Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid lysinate and 0.9% sodium-chloride solution in people with Critical Illness, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day Mortality (time frame: 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.