Trial Outcomes & Findings for Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit (NCT NCT02285153)

NCT ID: NCT02285153

Last Updated: 2019-12-18

Results Overview

Standard outcome measure of investigational intensive care unit trials.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 15 participants
• Primary outcome timeframe: 28-days
• Results posted on: 2019-12-18

Participant Flow

Participant milestones

Measure	Acetylsalicylic Acid Lysinate 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Overall Study STARTED	7	8
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Acetylsalicylic Acid Lysinate 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Overall Study Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Acetylsalicylic Acid Lysinate n=7 Participants 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 Participants 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=7 Participants	4 Participants n=8 Participants	9 Participants n=15 Participants
Age, Categorical >=65 years	2 Participants n=7 Participants	4 Participants n=8 Participants	6 Participants n=15 Participants
Age, Continuous	61 years STANDARD_DEVIATION 15 • n=7 Participants	63 years STANDARD_DEVIATION 10 • n=8 Participants	61 years STANDARD_DEVIATION 12 • n=15 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	2 Participants n=8 Participants	5 Participants n=15 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	6 Participants n=8 Participants	10 Participants n=15 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Austria	7 participants n=7 Participants	8 participants n=8 Participants	15 participants n=15 Participants
Simplified Acute Physiology Score III	64 score on a scale STANDARD_DEVIATION 19 • n=7 Participants	63 score on a scale STANDARD_DEVIATION 13 • n=8 Participants	64 score on a scale STANDARD_DEVIATION 15 • n=15 Participants

PRIMARY outcome

Timeframe: 28-days

Population: modified Intention to treat population (all patients who received at least a single dose of acetylsalicylic acid)

Standard outcome measure of investigational intensive care unit trials.

Outcome measures

Measure	Acetylsalicylic Acid Lysinate n=7 Participants 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 Participants 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
28-day Mortality	1 participants	1 participants

SECONDARY outcome

Timeframe: up to 90 days after inclusion

Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer

Outcome measures

Measure	Acetylsalicylic Acid Lysinate n=7 Participants 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 Participants 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Intensive Care Unit Mortality	2 participants	1 participants

SECONDARY outcome

Timeframe: average 28 days

clinically relevant thromboembolic events assessed by standard care, potentially longer

Outcome measures

Measure	Acetylsalicylic Acid Lysinate n=7 Participants 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 Participants 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial	0 participants	1 participants

SECONDARY outcome

Timeframe: average 28days

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

Outcome measures

Measure	Acetylsalicylic Acid Lysinate n=7 Participants 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 Participants 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Bleeding Incidences	1 counts	0 counts

Adverse Events

Acetylsalicylic Acid Lysinate

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

0.9% Sodium-chloride Solution

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Acetylsalicylic Acid Lysinate n=7 participants at risk 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 participants at risk 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Cardiac disorders Asystolia	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	0.00% 0/7 • 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.	25.0% 2/8 • Number of events 2 • 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.
Nervous system disorders hypoxic brain damage	0.00% 0/7 • 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.	12.5% 1/8 • Number of events 1 • 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.
Gastrointestinal disorders Colon Perforation	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Renal and urinary disorders Acute renal failure	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Product Issues Catheter infection	0.00% 0/7 • 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.	12.5% 1/8 • Number of events 1 • 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.

Other adverse events

Measure	Acetylsalicylic Acid Lysinate n=7 participants at risk 100mg Acetylsalicylic Acid Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day	0.9% Sodium-chloride Solution n=8 participants at risk 0.9% sodium-chloride solution 0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Vascular disorders Bleeding	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Cardiac disorders atrial fibrillation	0.00% 0/7 • 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.	12.5% 1/8 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • 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.	12.5% 1/8 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Nervous system disorders Delirium	28.6% 2/7 • Number of events 2 • 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.	12.5% 1/8 • Number of events 1 • 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.
General disorders Nausea	0.00% 0/7 • 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.	12.5% 1/8 • Number of events 1 • 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.
Gastrointestinal disorders Obstipation	0.00% 0/7 • 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.	12.5% 1/8 • Number of events 1 • 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.
Investigations Liver function test increased	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Infections and infestations Pneumonia	14.3% 1/7 • Number of events 1 • 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.	25.0% 2/8 • Number of events 2 • 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.
Infections and infestations catheter infection	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Infections and infestations Wound infection	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.
Infections and infestations Herpes Virus Infection	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/8 • 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.

Additional Information

Bernd Jilma

Medical University of Vienna

Phone: +434040029180

Email: bernd.jilma@meduniwien.ac.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place