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LIPS-A: Lung Injury Prevention Study With Aspirin

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ClinicalTrials.gov Identifier: NCT01504867
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : October 13, 2016
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Montefiore Medical Center
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Daryl J. Kor, M.D., Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Acute Respiratory Distress Syndrome
Interventions Drug: Aspirin
Drug: Lactose powder
Enrollment 400
Recruitment Details Participants were recruited between 1/2/2012 and 11/17/2014 at multiple US academic hospitals.
Pre-assignment Details  
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. This group received matching lactose powder filled capsules on days 1-7.
Period Title: Overall Study
Started 202 198
Completed 195 195
Not Completed 7 3
Reason Not Completed
Inclusion criteria not met             2             2
Consent revoked             5             1
Arm/Group Title Aspirin Placebo Total
Hide Arm/Group Description This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. This group received matching lactose powder filled capsules on days 1-7. Total of all reporting groups
Overall Number of Baseline Participants 195 195 390
Hide Baseline Analysis Population Description
400 subjects were randomized, and 10 subjects were excluded, leaving 390 in the final modified intention-to-treat analysis cohort.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 195 participants 195 participants 390 participants
57.0
(44.0 to 67.0)
57.0
(47.0 to 68.0)
57
(45 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 195 participants 390 participants
Female
88
  45.1%
99
  50.8%
187
  47.9%
Male
107
  54.9%
96
  49.2%
203
  52.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 195 participants 195 participants 390 participants
195 195 390
1.Primary Outcome
Title Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days
Hide Description ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.
Time Frame Within seven days from hospital presentation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: participants
20 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wald
Comments This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.
2.Secondary Outcome
Title Hospital Mortality
Hide Description [Not Specified]
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: participants
14 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With ARDS or Mortality Within 7 Days
Hide Description [Not Specified]
Time Frame within 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: participants
27 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization
Hide Description [Not Specified]
Time Frame approximately 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: participants
51 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Mean Number of Days Participants Were Ventilator-Free To Day 28
Hide Description [Not Specified]
Time Frame baseline, Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Mean (Standard Deviation)
Unit of Measure: days
24.9  (7.4) 25.2  (7.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects Admitted to Intensive Care Unit (ICU)
Hide Description [Not Specified]
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: participants
115 98
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Mean Hospital Length of Stay
Hide Description [Not Specified]
Time Frame approximately 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
This group received matching lactose powder filled capsules on days 1-7.
Overall Number of Participants Analyzed 195 195
Mean (Standard Deviation)
Unit of Measure: days
8.8  (10.3) 9.0  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. This group received matching lactose powder filled capsules on days 1-7.
All-Cause Mortality
Aspirin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/195 (2.05%)      8/195 (4.10%)    
Blood and lymphatic system disorders     
Hematoma   1/195 (0.51%)  1 0/195 (0.00%)  0
Anemia due to Upper GI Bleeding   0/195 (0.00%)  0 1/195 (0.51%)  1
Hemoptysis   0/195 (0.00%)  0 1/195 (0.51%)  1
Low Hemoglobin   0/195 (0.00%)  0 1/195 (0.51%)  1
Cardiac disorders     
Chest Pain   1/195 (0.51%)  1 0/195 (0.00%)  0
Pulseless Electrical Activity   0/195 (0.00%)  0 1/195 (0.51%)  2
Gastrointestinal disorders     
Bleeding Stress Ulcer   1/195 (0.51%)  1 0/195 (0.00%)  0
Gastrointestinal bleeding   1/195 (0.51%)  1 2/195 (1.03%)  2
Infections and infestations     
Pneumonia/Sepsis   0/195 (0.00%)  0 1/195 (0.51%)  1
Nervous system disorders     
Hydrocephalus   0/195 (0.00%)  0 1/195 (0.51%)  1
Renal and urinary disorders     
Urinary Tract Infection   0/195 (0.00%)  0 1/195 (0.51%)  1
Skin and subcutaneous tissue disorders     
Skin Infection   0/195 (0.00%)  0 1/195 (0.51%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/195 (6.67%)      5/195 (2.56%)    
Blood and lymphatic system disorders     
Bleeding   2/195 (1.03%)  2 0/195 (0.00%)  0
Thrombocytopenia   2/195 (1.03%)  2 0/195 (0.00%)  0
Cerebral Hemorrhage   1/195 (0.51%)  1 0/195 (0.00%)  0
Hematoma   1/195 (0.51%)  1 1/195 (0.51%)  1
Low Hemoglobin   0/195 (0.00%)  0 1/195 (0.51%)  1
Cardiac disorders     
NSTEMI   1/195 (0.51%)  1 0/195 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal Bleeding   2/195 (1.03%)  2 0/195 (0.00%)  0
Mild Indigestion   1/195 (0.51%)  1 0/195 (0.00%)  0
Vomiting   0/195 (0.00%)  0 1/195 (0.51%)  1
Infections and infestations     
Pneumonia   0/195 (0.00%)  0 1/195 (0.51%)  1
Renal and urinary disorders     
Rectal Bleeding   1/195 (0.51%)  1 0/195 (0.00%)  0
Urosepsis   1/195 (0.51%)  1 0/195 (0.00%)  0
Renal Failure Requiring Dialysis   0/195 (0.00%)  0 1/195 (0.51%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion   1/195 (0.51%)  1 0/195 (0.00%)  0
Surgical and medical procedures     
Right Hip Resection   1/195 (0.51%)  1 0/195 (0.00%)  0
Vascular disorders     
Elevated Blood Pressure   1/195 (0.51%)  1 0/195 (0.00%)  0
Nose Bleed   1/195 (0.51%)  1 0/195 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Daryl J. Kor
Organization: Mayo Clinic
Phone: 507-284-7678
Responsible Party: Daryl J. Kor, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01504867     History of Changes
Other Study ID Numbers: 10-004856
U01HL108712-01 ( U.S. NIH Grant/Contract )
KL2RR024151 ( U.S. NIH Grant/Contract )
K23HL112855 ( U.S. NIH Grant/Contract )
UL1TR000433 ( U.S. NIH Grant/Contract )
First Submitted: January 3, 2012
First Posted: January 6, 2012
Results First Submitted: August 17, 2016
Results First Posted: October 13, 2016
Last Update Posted: March 6, 2017