Status:
COMPLETED
LIPS-A: Lung Injury Prevention Study With Aspirin
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Montefiore Medical Center
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary hypothesis was that early aspirin administration will decrease the rate of developing acute lung injury during the first 7 days after presentation to the hospital.
Detailed Description
Acute respiratory distress syndrome (ARDS) remains a life-threatening critical care syndrome characterized by alveolar-capillary membrane injury and hypoxemic respiratory failure. The median time to o...
Eligibility Criteria
Inclusion
- Adult patients (age \> 18) admitted to the hospital through the emergency department (ED)
- At high risk of developing acute lung injury (ALI) Lung Injury Prediction Score (LIPS) greater than or equal to 4
Exclusion
- Anti-platelet therapy on admission or within 7 days prior to admission
- Presented to outside hospital ED \> 12 hrs before arrival at site's facility
- Inability to obtain consent within 12 hours of hospital presentation
- Admitted for elective surgery
- Acute lung injury prior to randomization
- Receiving mechanical ventilation through a tracheostomy tube prior to current hospital admission (patient who is ventilator dependent)
- Presence of bilateral pulmonary infiltrates on admission if he or she has a history of bilateral pulmonary infiltrates (as evidenced by previous x-rays) that can reasonably explain the current degree of pulmonary infiltrates present.
- Presentation due to pure heart failure and no other known risk factors for ALI.
- Allergy to aspirin or non steroidal anti inflammatory drugs (NSAIDs)
- Bleeding disorder
- Suspected active bleeding or judged to be at high risk for bleeding
- Active peptic ulcer disease (within past 6 months)
- Severe chronic liver disease
- Inability to administer the study drug
- Expected hospital stay \< 48 hours
- Admitted for comfort or hospice care
- Patient, surrogate or physician not committed to full support. (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Not anticipated to survive \> 48 hours
- Previously enrolled in this trial
- Enrolled in a concomitant intervention trial
- Pregnant or breastfeeding
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01504867
Start Date
January 1 2012
End Date
September 1 2015
Last Update
March 6 2017
Active Locations (16)
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1
Stanford Univeristy
Stanford, California, United States, 94305
2
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
3
University of Florida
Gainsville, Florida, United States, 32610
4
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224