Trial Outcomes & Findings for LIPS-A: Lung Injury Prevention Study With Aspirin (NCT NCT01504867)
NCT ID: NCT01504867
Last Updated: 2017-03-06
Results Overview
ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
400 participants
Primary outcome timeframe
Within seven days from hospital presentation
Results posted on
2017-03-06
Participant Flow
Participants were recruited between 1/2/2012 and 11/17/2014 at multiple US academic hospitals.
Participant milestones
| Measure |
Aspirin
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
198
|
|
Overall Study
COMPLETED
|
195
|
195
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Aspirin
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Overall Study
Inclusion criteria not met
|
2
|
2
|
|
Overall Study
Consent revoked
|
5
|
1
|
Baseline Characteristics
LIPS-A: Lung Injury Prevention Study With Aspirin
Baseline characteristics by cohort
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 years
n=5 Participants
|
57.0 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
195 participants
n=5 Participants
|
195 participants
n=7 Participants
|
390 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within seven days from hospital presentationPopulation: Intention-to-Treat
ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.
Outcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days
|
20 participants
|
17 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intention-to-Treat
Outcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Hospital Mortality
|
14 participants
|
14 participants
|
SECONDARY outcome
Timeframe: within 7 daysOutcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Number of Participants With ARDS or Mortality Within 7 Days
|
27 participants
|
21 participants
|
SECONDARY outcome
Timeframe: approximately 7 daysPopulation: Intention-to-Treat
Outcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization
|
51 participants
|
41 participants
|
SECONDARY outcome
Timeframe: baseline, Day 28Population: Intention-to-Treat
Outcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Mean Number of Days Participants Were Ventilator-Free To Day 28
|
24.9 days
Standard Deviation 7.4
|
25.2 days
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Intention-to-Treat
Outcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Number of Subjects Admitted to Intensive Care Unit (ICU)
|
115 participants
|
98 participants
|
SECONDARY outcome
Timeframe: approximately 7 daysPopulation: Intention-to-Treat
Outcome measures
| Measure |
Aspirin
n=195 Participants
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 Participants
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Mean Hospital Length of Stay
|
8.8 days
Standard Deviation 10.3
|
9.0 days
Standard Deviation 9.9
|
Adverse Events
Aspirin
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin
n=195 participants at risk
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 participants at risk
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Gastrointestinal disorders
Bleeding Stress Ulcer
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.51%
1/195 • Number of events 1 • 12 months
|
1.0%
2/195 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Hematoma
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Blood and lymphatic system disorders
Anemia due to Upper GI Bleeding
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Hemoptysis
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia/Sepsis
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Aspirin
n=195 participants at risk
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
|
Placebo
n=195 participants at risk
This group received matching lactose powder filled capsules on days 1-7.
|
|---|---|---|
|
Cardiac disorders
NSTEMI
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Vascular disorders
Nose Bleed
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Renal and urinary disorders
Rectal Bleeding
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Surgical and medical procedures
Right Hip Resection
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Renal and urinary disorders
Urosepsis
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Failure Requiring Dialysis
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/195 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Bleeding
|
1.0%
2/195 • Number of events 2 • 12 months
|
0.00%
0/195 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.0%
2/195 • Number of events 2 • 12 months
|
0.00%
0/195 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
2/195 • Number of events 2 • 12 months
|
0.00%
0/195 • 12 months
|
|
Blood and lymphatic system disorders
Cerebral Hemorrhage
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Vascular disorders
Elevated Blood Pressure
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
|
Blood and lymphatic system disorders
Hematoma
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.51%
1/195 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Mild Indigestion
|
0.51%
1/195 • Number of events 1 • 12 months
|
0.00%
0/195 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place