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Trial record 28 of 469 for:    aspirin AND prevention

LIPS-A: Lung Injury Prevention Study With Aspirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between 1/2/2012 and 11/17/2014 at multiple US academic hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Aspirin   Placebo
STARTED   202   198 
COMPLETED   195   195 
NOT COMPLETED   7   3 
Inclusion criteria not met                2                2 
Consent revoked                5                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
400 subjects were randomized, and 10 subjects were excluded, leaving 390 in the final modified intention-to-treat analysis cohort.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Aspirin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 195   195   390 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 57.0 
 (44.0 to 67.0) 
 57.0 
 (47.0 to 68.0) 
 57 
 (45 to 68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      88  45.1%      99  50.8%      187  47.9% 
Male      107  54.9%      96  49.2%      203  52.1% 
Region of Enrollment 
[Units: Participants]
     
United States   195   195   390 


  Outcome Measures

1.  Primary:   Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days   [ Time Frame: Within seven days from hospital presentation ]

2.  Secondary:   Hospital Mortality   [ Time Frame: 28 days ]

3.  Secondary:   Number of Participants With ARDS or Mortality Within 7 Days   [ Time Frame: within 7 days ]

4.  Secondary:   Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization   [ Time Frame: approximately 7 days ]

5.  Secondary:   Mean Number of Days Participants Were Ventilator-Free To Day 28   [ Time Frame: baseline, Day 28 ]

6.  Secondary:   Number of Subjects Admitted to Intensive Care Unit (ICU)   [ Time Frame: 7 days ]

7.  Secondary:   Mean Hospital Length of Stay   [ Time Frame: approximately 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Kor.Daryl@mayo.edu


Publications of Results:

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